News & Events zu Nyxoah SA (NYXH)NYXHNyxoah SA

Nyxoah ACCCESS Study Shows 12-Month AHI Responder Rate of 77.2%

Nyxoah announced that the ACCCESS U.S. pivotal study achieved statistically significant outcomes on its co-primary efficacy endpoints of 12-month AHI responder rate, per the Sher criteria, and 12-month Oxygen Desaturation Index, or ODI, responder rate, and met its safety endpoints, in patients with Complete Concentric Collapse, or CCC, of the soft palate. The ACCCESS study was designed to support the expansion of the Genio system's U.S. indication for CCC patients, who are contraindicated for commercially available unilateral hypoglossal nerve stimulation in this geography. At 12 months, patients demonstrated an AHI responder rate, per the Sher criteria, of 77.2% and an ODI responder rate of 87.7%, both on a Full Analysis Set basis. On safety, zero device-related serious adverse events were reported through 12 months post-implant. The results were generated in line with the prespecified statistical analyses planned in the study protocol as approved by the FDA. The primary analysis was performed on the Full Analysis Set of 47 patients, being all patients who were implanted, activated and completed at least one in-study sleep test. Missing data points were addressed through a multiple imputation model, the recognized statistical method prespecified as primary analysis in the protocol and statistical analysis plan. The complete 12-month dataset and detailed results are expected to be presented at the upcoming International Surgical Sleep Society annual meeting in Los Angeles, October 15-16. Nyxoah is preparing a premarket approval supplement submission to the FDA to expand Genio's indication to CCC patients under FDA Breakthrough Device Designation.

Nyxoah Reports Over 20% Sequential U.S. Revenue Growth in Q2

"We closed Q2 with clear U.S. momentum: the scaling of our U.S. sales force allowed us to double the number of active accounts to 180 high-volume HGNS accounts and deliver a second consecutive quarter of over 20% sequential U.S. revenue growth. Additionally, the recent CMS proposed reimbursement increases in both hospital outpatient and ambulatory surgical centers are among the strongest within APC 5465 and, if approved, support continued economic value for the Genio procedure," commented Olivier Taelman, Nyxoah's CEO. "With $110 million in new financing, the financial overhang is now behind us, and we are positioned to accelerate Genio's U.S. commercial ramp and drive toward profitability."

Company Expects 2026 Global Net Revenue of EUR 36M to EUR 40M

The company said, "The Company continues to expect global net revenue for the full year 2026 to be in the range of EUR 36 million to EUR 40 million."