Theranica Study to Support Expanded FDA Clearance for Nerivio
Theranica Bio-electronics has reported positive results from a clinical trial of its wearable neuromodulation device Nerivio for the preventive treatment of both episodic and chronic migraine.
The smartphone-controlled device, which is placed on the upper arm, stimulates the body's pain receptors to relieve acute and chronic migraine pain.
Participants who used Nerivio every other day experienced an average reduction of four migraine days per month from baseline compared to a reduction of 1.3 days in the placebo group.
Nerivio was initially approved to relieve symptoms of a migraine that has already started. The indications were later expanded to include patients 12 and older with episodic or chronic migraine.
Based on the positive study results, the company plans to file for additional FDA clearance for expanded use.