Nyxoah announced Sep. 14, 2021, that the FDA granted breakthrough device designation to its Genio bilateral hypoglossal nerve stimulation system, which is intended to treat adult patients with moderate to severe obstructive sleep apnea (OSA) and complete concentric collapse of the soft palate.
About the Genio system
The Genio system provides bilateral stimulation of the hypoglossal nerves. The system consists of a neurostimulator that is implanted under the chin, an activation chip, a charger and an adhesive patch. The neurostimulator is powered by the external activation chip, which is attached under the chin at night with the adhesive patch. There is no battery or sensor implanted in the body.
During sleep, the bilateral stimulation triggers a muscle contraction and tongue movement, resulting in the opening of the airway.
According to the company’s press release, under the breakthrough designation program, the FDA will provide the Genio system with priority review and interaction with FDA’s experts throughout the premarket review phase until the product is commercialized in the U.S.
About obstructive sleep apnea
OSA is a prevalent and serious sleep disorder where the airway becomes repeatedly blocked during sleep, leading to paused breathing and oxygen deprivation. Commonly caused by the collapse of throat tissues, it can result in loud snoring, choking noises and frequent awakenings, potentially contributing to health issues such as high blood pressure, heart disease, stroke, diabetes and depression.
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