Nyxoah has gained FDA approval for its Genio system, an implant for moderate-to-severe obstructive sleep apnoea, that offers a promising alternative to CPAP. The bilateral hypoglossal nerve-stimulating implant is powered externally (battery-free), smartphone-controlled, and delivered robust outcomes in its pivotal trial: a median reduction in the apnea–hypopnea index (AHI) of ~71%, with 82% of patients improving to at least the mild AHI range, irrespective of sleep posture.
However, Nyxoah’s U.S. commercialisation is now involved in litigation. On May 30, 2025, Inspire Medical Systems filed a patent-infringement suit, suggesting that Genio infringes three of Inspire’s U.S. patents covering neurostimulation therapy for obstructive sleep apnoea. Inspire’s technology, which was approved by the FDA in 2014 and has since been implanted in over 100,000 patients, uses a pacemaker-like unit implanted near the clavicle with leads to the hypoglossal nerve and a sensor for respiratory timing.
Inspire is looking for an injunction to block Genio’s U.S. entry, arguing that Nyxoah’s strategy – targeting high-volume implantation centres established by Inspire – relies on infringing technology to benefit from Inspire’s innovation and investment. Nyxoah, however, is ready to vigorously defend the product and proceed with its planned U.S. commercialisation.
Clinically, Genio’s bilateral hypoglossal nerve stimulation presents a novel design variant, offering a minimally invasive, externally powered neuromodulation approach that may enhance patient compliance.
