Nyxoah’s Genio implantable bilateral hypoglossal nerve stimulation for treatment of Obstructive Sleep Apnea
Image Credit: Nyxoah
I previously described efforts by Nyxoah, which was founded in 2009 by Robert Taub and Dr. Adi Mashiach in Mont-Saint-Guibert, Belgium, to develop neurostimulation treatments focused for Obstructive Sleep Apnea.
Last week (August 8, 2025), Nyxoah announced that FDA had approved its Genio System to treat 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.
Nyxoah developed a tiny, battery-less implantable neurostimulator that can electrically control the nerves of the tongue and so prevent airway blockage during sleep. The implant is powered and controlled by a disposable external adhesive patch. Every evening the OSA sufferer uses a new disposable patch that carries an “Activation Chip” that is positioned every night by the patient under the chin. The Activation Chip has its own battery and has enough energy to wirelessly activate the implanted neurostimulator for a full night sleep session.
According to the press release:
“The Genio system’s FDA approval was supported by the high-quality, differentiated safety and efficacy data from the Company’s DREAM pivotal trial. The DREAM study met both its primary and secondary endpoints demonstrating an AHI responder rate of 63.5% and an Oxygen Desaturation Index responder rate of 71.3%, with an overall median AHI reduction of 70.8%. Additionally, 82.0% of all DREAM subjects saw their AHI scores drop below 15 or lower.
Importantly, the DREAM study demonstrated that Genio is efficacious regardless of a patient’s sleeping position and, to our knowledge the only therapy with such clinical evidence in a large, multicenter, prospective clinical study using data from a full night polysomnography. This is a critical differentiator as on average, people sleep in a supine position between 35% and 40% of the night. The DREAM study measured position-specific outcomes and demonstrated a 66.6% median AHI reduction while patients slept in a supine position despite the fact that the number of airway obstructions can double in this position. This reduction compares favorably to the 71.0% reduction in AHI shown while patients slept in a non-supine position.”
