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.
In section Market Quotes
Nyxoah Sleep Apnea Device Clears Key Regulatory Hurdle
A clinical study of Nyxoah’s Genio system has met every primary safety and efficacy benchmark for patients suffering from complete concentric collapse of the soft palate. With these results in hand, the medical technology firm is moving to secure FDA approval to expand the device's use for this specific patient population.
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.
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