Nyxoah reports Q3 results (NYXH:NASDAQ)

Nyxoah SA (NYXH) reported Q3 2026 revenue of EUR9.2M, up 365% YoY. CEO Liam Kelly highlighted U.S. market opportunities, adjusted FY 2026 revenue guidance to EUR33M-EUR35M, and progress in CCC PMA supplement submission. The company trained 80 new surgeons and activated 53 new accounts. CMS reimbursement for Genio procedure increased by 11-13%. Cash position was EUR77.1M as of Q3 2026.

Nyxoah SA (NYXH) furnished an SEC Form 6-K — earnings release. Exhibit 99.1 REGULATED INFORMATION Nyxoah Reports Third Quarter 2026 Financial and Operating Results Global net revenue was €9.2 million driven by 29% sequential U.S. net revenue growth PMA supplement submitted to the FDA to expand Genio’s U.S. indication to include Complete Conc

Nyxoah SA (NYXH) presented 12-month data from its ACCCESS study on the Genio system for sleep apnea, meeting efficacy endpoints. AHI responder rate was 77.2%, ODI 87.7%. No device-related serious adverse events occurred. The company submitted a PMA supplement to the FDA to expand the Genio system's indication.

Nyxoah SA reported 12-month ACCCESS data showing a 74.3% median AHI reduction with Genio in CCC OSA patients. The company filed a PMA supplement with the FDA to expand Genio’s indication to CCC patients, with no serious adverse events reported. According to Nyxoah, a positive FDA decision could be a significant commercial catalyst.

Nyxoah SA (NYXH) shares rose 11.9% after its ACCCESS U.S. study met primary safety and efficacy endpoints. The Genio system showed a 77.2% Apnea-Hypopnea Index responder rate and zero device-related serious adverse events. The company plans to submit a premarket approval supplement to the FDA for expanded indication.

Nyxoah SA (NYXH) reported positive results from its ACCCESS trial for the Genio system in treating sleep apnea with Complete Concentric Collapse (CCC). The study met primary efficacy and safety endpoints, with 77.2% AHI responder rate and 87.7% ODI responder rate. NYXH shares rose 29.14% in overnight trading.