Nyxoah SA announced the upcoming release of efficacy and safety data from the DREAM US pivotal study on the Genio neurostimulation system for obstructive sleep apnea (OSA). The results are expected by early April, according to the company’s fourth-quarter and full-year 2023 financial and operating results. 

DREAM US is a multicenter study to assess the safety and effectiveness of the Genio dual-sided hypoglossal nerve stimulation system for the treatment of OSA in adult subjects. The Genio system has been CE-marked since 2019. The system is an investigational device in the United States.

“In 2023, we completed enrollment in our DREAM US pivotal study, presented positive early DREAM efficacy and safety data, initiated enrollment in our ACCCESS US pivotal study for complete concentric collapse, and raised capital from both existing and new investors. These accomplishments strengthen our confidence for a transformational 2024,” says Olivier Taelman, Nyxoah chief executive officer, in a release. “We are excited to report DREAM data in the coming weeks, finalize the regulatory FDA submission, and pave the way for bringing Genio to patients in the US.”

According to the company’s operating results, strategic priorities for 2024 are: 

  • Complete patient follow up in the DREAM US pivotal study and report efficacy and safety data by early April.
  • File the fourth and final module in the modular PMA submission.
  • Accelerate investments in the US commercial organization in preparation for a late 2024 launch.
  • Complete enrollment in the ACCCESS complete concentric collapse US pivotal study.
  • Increase hypoglossal nerve stimulation market penetration and Genio market share in Europe.

Taelman continues in the release, “Commercially in Europe, this quarter’s performance was the strongest in Nyxoah’s history driven by a targeted direct-to-consumer effort, and I applaud our European commercial team for their execution. I look forward to a further increase in therapy penetration from our partnership with ResMed in Germany.”