The study recorded a 77% response rate on the apnea-hypopnea index, a critical measure for assessing breathing disruptions during sleep. Over the 12-month observation period, researchers noted zero serious adverse events linked directly to the device. This safety profile marks a significant milestone as the company prepares a premarket approval supplement for the FDA under the agency’s breakthrough device designation.

Complete concentric collapse represents a challenging pattern of airway obstruction for clinicians. Currently, unilateral hypoglossal nerve stimulation is unavailable to these patients in the United States. By successfully targeting this group, Nyxoah aims to introduce a new therapeutic pathway for individuals who previously lacked viable options for managing their condition.