Over 83 million U.S. adults are estimated to live with obstructive sleep apnea, around 32% of the adult population. During sleep, repeated collapse of the upper airway disrupts breathing, fragmenting sleep and reducing oxygen levels. An estimated 80-90% of cases remain undiagnosed. For patients who cannot tolerate conventional treatments, neuromodulation can stimulate the hypoglossal nerve to activate tongue muscles and keep the airway open.
Belgium-based Nyxoah is expanding its battery-free approach, following FDA approval of its Genio system in 2025. This month, its ACCCESS pivotal study met its primary endpoints in a new group of sleep apnea patients, while the first patient was implanted in BREATHE, a five-year U.S. post-approval study. The milestones aim to broaden Genio’s addressable population while building longer-term evidence around the system as Nyxoah scales its U.S. rollout.
Nyxoah’s first September update came from ACCCESS, its U.S. pivotal study in patients with complete concentric collapse (CCC). At 12 months, 77.2% of patients met the study’s responder criteria for the apnea-hypopnea index (AHI), which measures breathing interruptions during sleep. Another 87.7% responded on the oxygen desaturation index (ODI), which tracks how often blood oxygen levels fall. No device-related serious adverse events were reported.
CCC is a pattern in which the soft palate collapses inward from all sides during sleep, further narrowing the airway. These patients are excluded from Inspire's U.S. indication, leaving part of the population without access to the market’s dominant system. Nyxoah is preparing an FDA application to expand Genio’s U.S. label to include CCC patients, a group it has already been cleared to treat in Europe since 2021.
Genio uses a different setup from most implanted sleep apnea systems. A small battery-free implant is placed under the chin and stimulates branches of both hypoglossal nerves, activating tongue muscles to help keep the airway open during sleep. The implant is wirelessly powered each night by a rechargeable activation chip worn under the chin, removing the implanted battery and sensing leads from competing systems.
Competition in hypoglossal nerve stimulation is expanding. Inspire remains the established U.S. player, while LivaNova received FDA approval for its aura6000 system in March 2026, although commercial launch is planned for 2027.
Nyxoah also announced a milestone in BREATHE, its U.S. post-approval study of Genio. The first patient was implanted on September 7, starting a study that will enroll up to 229 patients across as many as 25 U.S. centers. Participants will be followed for up to five years, tracking changes in breathing and oxygen levels alongside device and procedure-related safety.
BREATHE is part of the evidence that Nyxoah must collect following Genio’s FDA approval in August 2025. That approval was based largely on the DREAM pivotal study, where 63.5% of patients met the AHI responder criteria after 12 months. The new study will test how those results hold up over longer periods and across a broader set of U.S. treatment centers.
At the same time, Nyxoah is building out its commercial presence. U.S. revenue reached €5.2 million in the second quarter of 2026, up 22% from the previous quarter, with 180 active high-volume accounts and 262 trained surgeons by the end of June. Another 427 patients were moving through the insurance authorization process.
That expansion is backed by two tranches of funding. At the end of March, the company held €25.9 million in cash and financial assets while recording a €20.5 million quarterly operating loss, and had previously warned of substantial doubt around its ability to fund operations for another 12 months. In June, Nyxoah raised $95 million through an equity offering and another $15 million from the European Investment Bank, strengthening its position as it scales the U.S. rollout.
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