Nocria’s hand-held device uses gentle, controlled puffs of air in the ears for treating migraine attacks
Nocria is the first company to announce USFDA's Breakthrough Device designation for treating migraine attacks in both chronic and non-chronic migraine patients. USFDA’s Breakthrough Device program is designed to speed up access for caregivers and patients to life-changing medical devices.
In granting the Breakthrough Device designation, USFDA determined that Nocira's clinical data showed that the Nocira device provided a more effective treatment than other currently available drugs or devices. The device is discreet, soothing, non-invasive, fast acting, comfortable and easy to use, and does not rely on drugs.
With so many migraine therapies on the market, when someone says they have a breakthrough, patients tend to take it with a grain of salt. Except, of course, when the word "breakthrough" is associated with a special designation by the USFDA. Today, Nocira is pleased to announce its device, which uses gentle, controlled puffs of air in the ears (called "Automated Variable Pulse Insufflation or AVPI), was officially designated by the USFDA as a "Breakthrough Device" for the acute treatment of migraine by patients 18 years or older.
"In granting this Breakthrough Device designation, the FDA was required to determine that the clinical data supporting the Nocira device provides a reasonable expectation for a more effective treatment versus other available therapies for acutely treating migraine attacks," says Melissa Walker, MS RAC FRAPS, Nocira's VP of Regulatory, Quality, and Clinical Affairs.
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