Nyxoah SA, a medical technology company developing solutions to treat obstructive sleep apnea, announced it has completed all 115 implants in its DREAM US pivotal study, submitted the first module in the modular DREAM premarket approval submission, and implanted the first patient in the ACCCESS US pivotal study.
The DREAM study is an investigational device exemption trial designed to support the marketing authorization of the Genio neurostimulator system 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 responder rate, per the Sher criteria, and the oxygen desaturation index responder rate, both at 12 months.
In the ACCCESS trial, Nyxoah will implant 106 complete concentric collapse (CCC) patients with co-primary efficacy endpoints of apnea-hypopnea index responder rate, per the Sher criteria, and oxygen desaturation index responder rate, both assessed at 12 months post-implant.
“The achievement of these key clinical and regulatory milestones brings us closer to offering our patient-centric Genio solution to all OSA patients in the US. The DREAM and ACCCESS studies demonstrate Nyxoah’s mission of providing Genio to patients regardless of CCC status and without the requirement for a CCC diagnosis,” says Olivier Taelman, Nyxoah CEO, in a press release.
Following the successful completion of the BLAST OSA study, the Genio system received its European CE Mark in 2019. Following the positive outcomes of the BETTER SLEEP study, Nyxoah received CE mark approval for the expansion of its therapeutic indications to CCC patients, currently contraindicated in competitors’ therapy.
The company is currently conducting the DREAM investigational device exemption study for FDA and US commercialization approval.