Nyxoah (NYXH) Begins BREATHE Study. Can Real-World Evidence Drive Genio Adoption?

Nyxoah SA (NASDAQ:NYXH) initiated the initial patient implantation in its BREATHE study on September 7. This prospective, single-arm research in the United States will examine Genio hypoglossal-nerve stimulation in adults aged 22 or older suffering from moderate to severe obstructive sleep apnea who have not found success with standard care treatments.

Up to 229 patients at up to 25 centers are expected to participate, with follow-up lasting up to five years. This milestone marks the start of a new phase in collecting evidence for Genio, since it received FDA approval in August 2025. The primary effectiveness measures are responder rates for the apnea-hypopnea-index and oxygen-desaturation-index at 12 months, while device- and procedure-related serious adverse events will be assessed at 12 months and annually thereafter.

Nyxoah SA (NASDAQ:NYXH) aims to demonstrate Genio's performance across various physicians and treatment settings, as consistent outcomes could instill confidence in patient selection and treatment delivery among referring sleep physicians and implanting surgeons. The study's value lies in reducing uncertainty along the treatment pathway and building a more repeatable source of implant demand if physicians become more comfortable recommending Genio and reimbursement supports procedures.