05:13 PM EDT, 03/19/2024 (MT Newswires) -- Nyxoah ( NYXH ) said late Tuesday a US study of the company's Genio system to treat obstructive sleep apnea reached its primary endpoints.

The trial enrolled 115 people and has co-primary endpoints of the Apnea-Hypopnea Index responder rate and the Oxygen Desaturation Index responder rate, Nyxoah ( NYXH ) said.

The study reached a "statistically significant" decrease in the co-primary endpoints of 12-month Apnea-Hypopnea Index responder rate and Oxygen Desaturation Index responder rate, the company said.

"Subjects demonstrated a median 12-month AHI reduction of 70.8%, with similar AHI improvements in supine and non-supine sleeping positions," Nyxoah ( NYXH ) said.

The company said it's finalizing a premarket approval filing with the US Food and Drug Administration, and plans to launch Genio in the US, pending the regulator's clearance.

Nyxoah ( NYXH ) shares rose 3.5% in recent after-hours trading.

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