Summary: Nyxoah SA has appointed Scott Holstine as chief commercial officer to lead the expected US launch of the Genio neurostimulator for obstructive sleep apnea (OSA). The Genio system, which has already received the CE Mark in Europe, is expected to receive FDA approval by … [Read more...]
Genio OSA: Nyxoah Submits Final PMA Application to FDA
Summary: Nyxoah has submitted the fourth and final module of its Premarket Approval (PMA) application to the FDA for its Genio neurostimulator, designed to treat obstructive sleep apnea (OSA). The Genio system, which is fully-body MRI-compatible and powered by a wearable, … [Read more...]
Nyxoah Prepares Final FDA Module for Genio OSA Neurostimulator
Summary: Nyxoah described its Q1 2024 economic and operating outcomes, highlighting sizeable progress with its Genio program, a leadless and battery-cost-free hypoglossal neurostimulation therapy for obstructive snooze apnea (OSA). The Aspiration US pivotal study reached co-key … [Read more...]
Genio Neurostimulator Reduces Sleep Apnea Severity
Nyxoah SAs Desire US pivotal analyze, made to assist the advertising and marketing authorization of the Genio hypoglossal nerve stimulation procedure for obstructive sleep apnea in the United States, achieved a statistically substantial reduction in the co-key endpoints of … [Read more...]