Nyxoah Gets FDA IDE Approval to Begin Genio Study

The FDA granted Belgium-based Nyxoah an Investigational Device Exemption (IDE) to begin a clinical trial to evaluate its Genio system for treatment of moderate-to-severe obstructive sleep apnea and collapse of the soft palate.

The CE-marked device functions as part of a bedtime routine that involves the connection of an activation chip to a disposable patch applied under the chin. The chip and patch transmit energy to an implantable stimulator that triggers a small forward movement of the back of the tongue and maintains an open upper airway during sleep.

An IDE allows an investigational device to be used in a clinical study in order to collect safety and effectiveness data. Clinical studies are most often conducted to support a premarket approval application, but a small percentage of 510(k) marketing clearance submissions also require supporting clinical data.