Nyxoah's ACCCESS Trial Of Genio System Meets Primary Goals In CCC Sleep Apnea Patients; Shares Jump

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) furnished an SEC Form 6-K — earnings release. ​ Exhibit 99.1 REGULATED INFORMATION Nyxoah Reports Second Quarter and First Half 2026 Financial and Operating Results U.S. commercial execution driving continued launch momentum resulting in 22% sequential U.S. revenue growth in Q2 2026 over Q1 2026 Mont-Saint-Guibert, Belgium –

Nyxoah SA (NYXH) reported Q2 2026 net revenue of €7.7 million, up from €1.3 million a year earlier, with U.S. net revenue €5.2 million, 22% higher sequentially. First-half 2026 net revenue was €14.0 million. The company secured $110 million financing, had €97.8 million cash at June 30, and guided FY2026 revenue €36-40 million and gross margin 60-62%.

Nyxoah SA said its Genio U.S. launch is gaining traction, citing 262 trained surgeons, 123 ordering customers, and 427 patients in prior authorization. It reported early launched accounts reached 15% market share in six months and said reimbursement is stable, with CMS code changes not affecting coverage and prior authorization approvals at a 100% rate. Nyxoah reiterated 2026 revenue guidance of EUR 36m to EUR 40m and noted a preliminary cash balance of EUR 98m.