Nyxoah SA, a medical technology company developing solutions to treat obstructive sleep apnea, will present preliminary, 12-month data on the first 34 patients in the DREAM trial at SLEEP 2023 in Indianapolis.
The DREAM study is an investigational device exemption trial designed to support the marketing authorization of the Genio neurostimulator system for the treatment of sleep apnea in the United States. This multicenter, prospective, open-label, observational study enrolled 115 patients and has co-primary efficacy endpoints of the apnea-hypopnea index (AHI) responder rate, per the Sher criteria, and the oxygen desaturation index (ODI) responder rate, both at 12 months.
The preliminary data shows patients demonstrated a 65% AHI responder rate, a 76% ODI responder rate, and safety was in line with expectations. Full abstract results will be presented in a late-breaking poster session on June 6.
Nyxoah provided the updates as part of its first-quarter financial and operating results. Other highlights for the quarter include:
- Completed all 115 implants in the DREAM US pivotal trial, with full 12-month data on expected in the first quarter of 2024.
- Initiated the modular premarket approval submission with the filing of the first module.
- Implanted the first patients in the ACCCESS US investigational device exemption pivotal study to treat complete concentric collapse. Implant completion is expected in 2024.
- Ended the quarter with 40 active German accounts.
- Expanded European market access with the first implants in Austria.
- Strengthened the supply chain with the Belgium manufacturing facility receiving clearance from the EU-notified body.
- Hired Christoph Eigenmann as chief commercial officer.
- Raised €19 million from new and historical shareholders including ResMed, Cochlear, and Robert Taub, Nyxoah’s chairman and founder.
“In 2023, our focus is in the US on DREAM patient follow up resulting in reaching the primary endpoints. I am excited by the data on the first 34 patients and look forward to sharing the full abstract results at SLEEP 2023 next month. Our increasing conviction in DREAM outcomes is accelerating investment in our commercial organization, starting with the addition of Christoph as chief commercial officer,” says Olivier Taelman, Nyxoah’s CEO, in a release. “Christoph’s hire, along with the €19 million raised from key investors, puts us in a strong position as we embark on our next stage of growth.”