Clinical EfficacyGenio system resulted in a clinically meaningful 71.0% median reduction in Apnea Hypopnea Index (AHI) while sleeping supine at 12 months compared with baseline.
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.