Nyxoah Sleep System Met Safety and Efficacy Goals
The Genio hypoglossal nerve stimulation system met primary endpoints in the 47-patient ACCCESS study.
Updated on Oct. 14, 2026 in Stroke
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The ACCCESS clinical study of the Genio hypoglossal nerve stimulation system has met all primary safety and efficacy goals for treating patients with sleep-related breathing issues. Nyxoah is now preparing to submit a premarket approval supplement to the FDA to expand the system’s use.
Why it matters
The study was designed to expand the indicated use of the Genio system to patients suffering from complete concentric collapse of the soft palate. Successful results provide clinical evidence for this specialized treatment path.
The ACCCESS study reported an 87.7% ODI responder rate and 77.2% AHI responder rate among 47 participants. No device-related serious adverse events were recorded through 12 months post-implant.
The players
Nyxoah
Nyxoah is a medical technology company that develops neurostimulation solutions for sleep-disordered breathing.
FDA
The Food and Drug Administration is the federal agency responsible for regulating medical devices and approving clinical indications for use in the United States.
The details
The Genio system uses hypoglossal nerve stimulation to assist patients with complete concentric collapse of the soft palate. The study tracked participants who were implanted, activated, and completed at least one in-study sleep test.
Timeline
Responder rates and safety metrics were measured at 12 months post-implant.
Results are scheduled for presentation on October 15-16, 2026.
The Big Picture
The study follows a pattern set by clinical trials presented at the International Surgical Sleep Society, where companies debut safety and efficacy data. The results provide a new benchmark for hypoglossal nerve stimulation as a treatment for complete concentric collapse.
Pending FDA approval, the system could provide a new treatment option for patients who specifically suffer from complete concentric collapse of the soft palate. This may expand the availability of neurostimulation therapies for those who have not responded to other sleep treatments.
The takeaway
The ACCCESS study confirms the safety and utility of the Genio system for a specific subset of sleep-breathing patients. Patients should discuss new neurostimulation options with their healthcare providers as more regulatory data becomes available.
Further reading
For more information on similar medical technology, visit the United States Stroke section.
Source note: This article includes information reported by Sleep Review.
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