BELGIUM – March 6, 2023, 7:30am CET / 1:30am ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA), today announced that the Company has completed all 115 implants in its DREAM U.S. pivotal study, submitted the first module in the modular PMA submission and implanted the first patient in the ACCCESS U.S. pivotal study.
The DREAM study is a pivotal, investigational device exemption (IDE) trial designed to support the marketing authorization of the Genio® hypoglossal nerve stimulation system (HGNS) 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.
In the ACCCESS trial, Nyxoah will implant 106 complete concentric collapse (CCC) patients with co-primary efficacy endpoints of Apnea-Hypopnea Index (AHI) responder rate, per the Sher criteria, and Oxygen Desaturation Index (ODI) 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 U.S. 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,” commented Olivier Taelman, Nyxoah’s Chief Executive Officer.
About Nyxoah
Nyxoah is a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA). Nyxoah’s lead solution is the Genio® system, a patient-centered, leadless and battery-free hypoglossal neurostimulation therapy for OSA, the world’s most common sleep disordered breathing condition that is associated with increased mortality risk and cardiovascular comorbidities. Nyxoah is driven by the vision that OSA patients should enjoy restful nights and feel enabled to live their life to its fullest.
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 Complete Concentric Collapse (CCC) patients, currently contraindicated in competitors’ therapy. Additionally, the Company is currently conducting the DREAM IDE pivotal study for FDA and US commercialization approval.
