Nyxoah Earns FDA Approval for Genio Sleep Apnea Neurostim

Nyxoah has earned U.S. Food and Drug Administration (FDA) approval for its Genio neuromodulation system to treat patients with moderate to severe obstructive sleep apnea (OSA) with an Apnea-Hypopnea Index (AHI) of greater than or equal to 15 and less than or equal to 65.

Genio is touted as a different approach to hypoglossal nerve stimulation (HGNS) to treat OSA. It uses bilateral stimulation with a leadless, full-body 1.5T and 3T MRI-compatible, non-implanted battery solution, powered and controlled by a wearable component. The wearable is upgradeable without further surgeries required.

The company’s DREAM pivotal trial showed a 63.5% AHI responder rate and 71.3% Oxygen Desaturation Index responder rate. There was an overall median AHI reduction of 70.8%, with 82% of all DREAM subjects seeing AHI scores drop below 15 or lower.

The study also demonstrated Genio is effective regardless of the patient’s sleeping position.

Colin Huntley MD, Associate Professor, Department of Otolaryngology Head & Neck Surgery, Thomas Jefferson University said Genio’s approval is a major addition to treatment options available to doctors treating OSA patients.

“This unique bilateral stimulation technology has demonstrated consistent efficacy across all sleeping positions, including the challenging supine position, while maintaining an excellent safety profile,” Dr. Huntley told the press.

“Today marks a defining moment for Nyxoah and for U.S. patients suffering from OSA. With the FDA’s marketing approval of the Genio system, we are proud to bring this innovative therapy to the U.S. market,” added Olivier Taelman, Nyxoah’s CEO. “Our mission has always been to make sleep simple for OSA patients by offering them a solution that empowers better sleep. We look forward to the successful execution of our U.S. commercialization strategy.”