Nyxoah’s Sleep Apnea System Gains Breakthrough Device Designation
Nyxoah has received the FDA’s Breakthrough Device designation for its Genio nerve stimulation system for sleep apnea.
The Genio system is intended to treat adult patients with moderate-to-severe obstructive sleep apnea (OSA) and complete concentric collapse of the soft palate — which occurs when the muscles around the soft palate relax so much that the tissue collapses and blocks the airway.
The new designation was supported by data from the company’s Better Sleep trial of the system in adults with OSA. Top-line results showed a statistically significant improvement in the Apnea-Hypopnea Index score in the full patient population, the company said.