New Milestone in Sleep Apnoea Device Trial

Image credit: Nyxoah

Belgium-based medtech, Nyxoah has announced a significant milestone in its pivotal trial for its hypoglossal nerve stimulation system for treating adults with moderate to severe obstructive sleep apnoea (OSA).

The Genio technology has met the co-primary endpoints at 12 months in its open-label pivotal DREAM trial, with 115 enrolled patients in sites across Australia, the US and Europe.

At 12 months, participants had a median apnoea-hypopnea index reduction of 70.8 percent, with the trial also reporting an oxygen desaturation index responder rate of 71.3 percent. The study demonstrated a serious adverse event rate of 8.7 percent.

Genio is a leadless, battery-free device that delivers bilateral hypoglossal nerve stimulation to prevent the tongue from falling back and obstructing the upper airway during sleep.

It was developed as an alternative therapy option for patients who cannot tolerate conventional continuous positive airway pressure (CPAP) approaches to treating OSA.

“I am excited to report the positive DREAM results, as they pave the way for Genio to shift the OSA treatment paradigm in the US,” said Nyxoah CEO, Olivier Taelman in a statement.

“With Genio’s patient centric design, strong clinical data and commercial learnings from Europe, we are confident Nyxoah can become a leading OSA company.”

The company said the trial data would support its bid for marketing authorisation in the US, having already received European CE marking in 2019.

Refer to the press release from Nyxoah for further information.