Clinical PerformanceNyxoah announced that 82.0% of patients who completed a polysomnography at 12 months had an AHI below 15 and that 67.4% of patients had an AHI below 10.
Market OpportunityThe target market for Genio in the U.S. is approximately 510,000 patients, representing an annual total addressable market of approximately $10 billion.
Regulatory ApprovalThe FDA has issued an Approvable Letter for Nyxoah's Genio system, indicating a positive step towards full market approval.