Nyxoah SA (NYXH) Reports 74.3% AHI Median Reduction; Files FDA PMA Supplement
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.


