Theranica’s Nerivio Gains FDA 510(k) Nod For Migraine Prevention Device

Theranica’s Nerivio Gains FDA 510(k) Nod For Migraine Prevention Device, Theranica Bio-Electronics’ wearable gadget for alleviating migraine symptoms, approved by the FDA in 2019, might soon adopt a more aggressive strategy regarding that treatment.

The FDA approved the company’s request for wider use of the technology only a few months after it had filed a revised 510(k) petition with the agency. Theranica revealed this week that the Nerivio neuromodulation band, available exclusively with a doctor’s prescription, may now be used to prevent migraines in addition to curing their symptoms.

Those experiencing migraines (with or without aura) and who are aged minimum 12 years old now have the authorization to use the device for prevention. Acute therapy with Nerivio was first approved for use exclusively in adults, but its label was eventually expanded to include the same age bracket roughly two years later.

The Nerivio gadget consists of an armband that the user wraps over their upper arm and a mobile application that controls the device’s on/off status and intensity level. During each session, electrical pulses are sent from electrodes in the band to the patient’s nerve fibers. These pulses aren’t harmful to the wearer in any way, but they’re supposed to activate the body’s natural pain-control systems, which will then distribute calming sensations up the user’s nerve system and into their brain.

This method has been shown to be effective as an acute therapy for migraine, and new research from last year demonstrated that preventing migraines from ever manifesting by promoting pain relief across the neural system prior to their onset is also feasible.

About 250 participants with either chronic or episodic migraines were included in the research. Following eight weeks of therapy, individuals given the Nerivio band reported a four-day monthly reduction in migraine days, whereas those given a placebo reported a decrease of just 1.3 days. On average, the gadget helped people with chronic migraines cut back on their headaches by 4.7 days per month, as compared to 3.2 days for those with episodic migraines. 

Theranica suggests 45-minute sessions on alternate days for preventative purposes, although patients have complete autonomy over their schedules.

CEO Alon Ironi stated in an interview last year following the announcement of the research results and the new FDA application that permitting the Nerivio technology to be utilized in both preventative and severe treatment would render it a far more essential and effective therapy.

Theranica has increased the neurostimulation capability of the gadget now that it has dual-use approval; each Nerivio unit may be used for 18 therapy sessions instead of the prior limit of 12. Units are priced at $599, but the firm claims that with insurance and its savings scheme, customers can spend as little as $10 for the initial unit and $49 for refills.

Statement front the CEO: 

“That means, first of all, less dependency on pharmacological agents. It also means less burden, because if you only have one therapy that you have to adhere to, it’s fewer things to worry about,” Ironi remarked. “If you manage to get both significant reductions in your migraine episodes as well as to abort whatever episodes you do experience with the same therapy, that makes your life easier.”

Also Read: Death toll linked to Phillips’ respiratory device recall reaches 364