Nyxoah, a medical technology company that develops treatment alternatives for Obstructive Sleep Apnea (OSA) through neuromodulation, announced that the FDA has approved the Genio system for a subset of patients with moderate to severe OSA with an Apnea-Hypopnea Index (AHI) of greater than or equal to 15 and less than or equal to 65.
Genio is a different approach to hypoglossal nerve stimulation (HGNS) for the treatment of OSA. The device's design uses bilateral stimulation, and offers patients a leadless, full-body 1.5T and 3T MRI compatible, non-implanted battery solution, powered and controlled by a wearable component. The wearable component is fully upgradable, providing Genio patients with access to this technology without requiring additional surgeries for technology updates or battery replacements.
"The Genio system's approval represents a major addition to the treatment options available to physicians treating patients with OSA,” said Colin Huntley MD, Associate Professor, Department of Otolaryngology Head & Neck Surgery, Thomas Jefferson University. “This unique bilateral stimulation technology has demonstrated consistent efficacy across all sleeping positions, including the challenging supine position, while maintaining an excellent safety profile.”
