Nyxoah ACCCESS data show 74% AHI cut in CCC sleep apnoea patients

Full 12-month pivotal data for Nyxoah's Genio device in CCC patients support a PMA supplement filed with the FDA for expanded US indication.

The Biotech Times Editorial Team By The Biotech Times Editorial Team AI level 2 of 5
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A white circular device rests on a wooden nightstand in a sunlit bedroom, with white bedding and pillows visible in the background.

Nyxoah has presented the complete 12-month results of its ACCCESS US pivotal study at the International Surgical Sleep Society annual meeting in Los Angeles, showing strong efficacy and a clean safety record for its Genio bilateral hypoglossal neurostimulation system in patients with Complete Concentric Collapse (CCC) of the soft palate.

The findings confirm topline data released in September 2026. In the per-protocol population, mean Apnea-Hypopnea Index (AHI) fell from 33.6 to 10.4 events per hour, a median reduction of 74.3% from baseline. Oxygen Desaturation Index (ODI) improved by a median of 71.9%. Both co-primary efficacy endpoints were met at statistical significance (p<0.001): AHI responder rate of 77.2% and ODI responder rate of 87.7% on a full analysis set basis. No device- or procedure-related serious adverse events were recorded over the 12-month follow-up period.

Patient-reported outcomes reinforced the objective findings. Mean Epworth Sleepiness Scale score improved by 5.3 points and the Functional Outcomes of Sleep Questionnaire score by 2.3 points. Almost all participants (94.7%) reported an improvement, and 97.4% said they would choose the implant again.

Regulatory path

On the same day as the ISSS presentation, Nyxoah submitted a premarket approval (PMA) supplement to the US Food and Drug Administration seeking to expand the Genio system's indication to cover CCC patients. The company received initial FDA approval for Genio in August 2025 for moderate-to-severe OSA, though at that stage treatment of CCC patients was flagged in the warnings section rather than as an approved indication.

Edward Mezerhane, sleep medicine physician at PharmaDev Clinical Research Institute and co-principal investigator of ACCCESS, said the data "could give US physicians an additional therapeutic approach for OSA patients with CCC," adding that there is currently no commercially available hypoglossal nerve stimulation option for this population in the United States. The Genio system has carried CE mark approval for CCC patients in Europe since 2021.

Market context

CCC is estimated to affect a meaningful proportion of OSA patients who are candidates for surgical intervention, yet it represents a contraindicated population for unilateral hypoglossal nerve stimulators currently approved in the US, most notably Inspire Medical Systems' device. That contraindication creates a clinical gap that Nyxoah is explicitly targeting. If the PMA supplement is approved, Genio would be the only neurostimulation therapy in the US cleared for CCC patients, a commercially significant differentiator in what is otherwise an intensely competitive sleep-disordered breathing device market.

The broader hypoglossal nerve stimulation market has grown substantially since Inspire's initial FDA clearance in 2014, driven by increasing awareness of OSA's cardiovascular comorbidities and improving reimbursement. Nyxoah's leadless, battery-free architecture is distinct from Inspire's implanted pulse generator design, and the company has positioned this as an advantage in surgical simplicity and longevity. The outcome of FDA review of the PMA supplement will be the next critical milestone; no target action date has been disclosed. Patients enrolled in ACCCESS will continue to be followed through three years post-implant, with longer-term data expected to inform any post-market commitments the FDA may attach to approval.

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