Nyxoah prepares FDA PMA supplement to expand Genio sleep apnea indication to CCC patients
NYXH•FDA supplement prepared to expand Genio indication
Nyxoah began preparing an FDA PMA supplement to expand Genio’s US indication to patients with complete concentric collapse.
- The move follows the ACCCESS pivotal study meeting 12-month primary safety, AHI, and ODI endpoints in the full analysis set.
