Nyxoah files FDA PMA supplement after 12‑month ACCCESS study shows strong efficacy
Nyxoah SA presented 12‑month results from its ACCCESS pivotal study of the Genio hypoglossal nerve stimulation system in patients with complete concentric collapse of the soft palate. The study met both co‑primary endpoints, with an AHI responder rate of 77.2% and an ODI responder rate of 87.7%, and a median AHI reduction of 74.3% from baseline. No device‑ or procedure‑related serious adverse events were reported, and the company submitted a pre‑market approval supplement to the FDA to expand the Genio indication.
Why it matters
The company says FDA approval of the expanded indication could be a significant commercial catalyst. If approved, the broader patient pool may increase future sales of the Genio system.
Key facts
- 1Nyxoah presented complete 12‑month ACCCESS study results at the International Surgical Sleep Society meeting in Los Angeles on Tuesday. investing.com
- 2The study met both co‑primary efficacy endpoints, with an Apnea‑Hypopnea Index responder rate of 77.2% (full analysis set). investing.com
- 3The Oxygen Desaturation Index responder rate was 87.7% (full analysis set). investing.com
- 4Mean AHI fell from 33.6 to 10.4 events per hour, a median reduction of 74.3% from baseline. investing.com
- 5No device‑ or procedure‑related serious adverse events occurred through 12 months. investing.com
- 6Nyxoah submitted a pre‑market approval supplement to the U.S. FDA to expand the Genio system’s indication to complete concentric collapse patients. investing.com
Summary written by AlphAI AI Desk from 2 of 2 sources. Not investment advice. Figures are as stated by the linked sources.