Nyxoah ACCCESS study hits safety and efficacy endpoints in CCC patients
Nyxoah has reported that its ACCCESS U.S. pivotal study met co-primary safety and efficacy endpoints for the Genio hypoglossal neurostimulation system in patients with Complete Concentric Collapse (CCC) of the soft palate, a subgroup currently contraindicated for all commercially available unilateral hypoglossal nerve stimulation devices in the United States.
At 12 months, 77.2% of implanted patients met the Sher criteria for AHI response, defined as at least a 50% reduction from baseline and an AHI below 20 events per hour, against a p-value of less than 0.001. The co-primary Oxygen Desaturation Index responder rate reached 87.7% (p<0.001). Both figures were calculated on a Full Analysis Set of 47 patients who were implanted, activated, and completed at least one in-study polysomnography. Critically, the company reported zero device-related serious adverse events through 12 months post-implant.
Clinical significance
Colin Huntley, Professor of Otolaryngology at Thomas Jefferson University and co-principal investigator of the ACCCESS study, said the findings could give US physicians "a new treatment option for the vast number of OSA patients with CCC who have struggled with positive airway pressure." CCC accounts for a meaningful proportion of OSA diagnoses, yet until now has been outside the approved use of any neurostimulation device in the United States. Genio has carried a CCC-inclusive CE mark in Europe since 2021, following the earlier BETTER SLEEP study, so Nyxoah has existing commercial evidence from that geography.
Chief executive Olivier Taelman confirmed the company is preparing a premarket approval supplement submission to the FDA, which granted the Genio system Breakthrough Device Designation for this indication. Full 12-month data are due to be presented at the International Surgical Sleep Society annual meeting in Los Angeles on 15-16 October 2026. Nyxoah received FDA clearance for the broader Genio system in August 2025, following positive outcomes from the DREAM IDE pivotal study in 2024.
Market and competitive context
The hypoglossal nerve stimulation market in the United States has to date been dominated by Inspire Medical Systems, whose Inspire device holds the established market position but carries the same CCC contraindication. If Nyxoah's PMA supplement is approved, it would create a meaningful clinical differentiator: the Genio system would be the only FDA-cleared neurostimulation option available to CCC patients, a population that currently has no approved device-based alternative beyond continuous or bilevel positive airway pressure.
OSA is widely recognised as an undertreated condition with significant cardiovascular and metabolic comorbidities, and device-based therapy is growing as CPAP non-adherence remains a persistent clinical problem. Analysts tracking this space will be watching PMA supplement timelines carefully; PMA supplements under Breakthrough Device Designation typically receive prioritised FDA review, which can compress timelines relative to standard PMA tracks, though the agency does not guarantee specific timeframes.
Nyxoah's Genio platform is distinguished by a leadless, battery-free architecture, which the company positions as reducing implant complexity and eliminating the need for battery replacement procedures. Whether those design differences translate into durable commercial advantage will depend on real-world adoption data and longer-term follow-up from the three-year ACCCESS observation window. Investors will also be looking for clarity on the US commercial launch plan and expected pricing relative to established competitors before drawing conclusions about the revenue trajectory following any potential approval.