Nyxoah said a U.S. study of its obstructive sleep apnea (OSA) device met all primary safety and efficacy endpoints in patients with complete concentric collapse (CCC) of the soft palate.

The medical technology company said Wednesday it is now preparing a premarket approval supplement submission to the Food and Drug Administration to expand its Genio system's indication to CCC patients under the FDA's breakthrough device designation.

The study showed a 77% apnea-hypopnea index response rate, with zero device-related serious adverse events through 12 months, the company said.

The results could give a new treatment option to U.S. patients with CCC, a pattern of airway collapse common in patients with OSA, the company said. Unilateral hypoglossal nerve stimulation is not currently an option for OSA patients with CCC in the U.S., the company said.