Nyxoah SA (NASDAQ:NYXH) announced the first patient implantation in BREATHE on September 7. The prospective, single-arm U.S. post-approval study will evaluate Genio hypoglossal-nerve stimulation in adults aged 22 or older with moderate to severe obstructive sleep apnea for whom standard-care treatments have failed, cannot be tolerated, or are unsuitable. Plans call for up to 229 patients at up to 25 centers, with follow-up lasting up to five years.
For Nyxoah SA (NASDAQ:NYXH), the milestone begins a new phase of evidence collection following Genio's August 2025 FDA approval. The co-primary effectiveness endpoints are apnea-hypopnea-index and oxygen-desaturation-index responder rates at 12 months. Device- and procedure-related serious adverse events will be **** sed at 12 months and annually thereafter. The investment question is whether that evidence can help turn clinical credibility into sustained commercial adoption.
Nyxoah SA (NASDAQ:NYXH) has an opportunity to demonstrate how Genio performs across different physicians and treatment settings. Consistent outcomes across participating centers could give referring sleep physicians and implanting surgeons greater confidence in patient selection and treatment delivery.
The product offers a distinct approach. Genio stimulates hypoglossal nerves on both sides of the tongue, using a battery-free implant powered by an external wearable. For Nyxoah SA (NASDAQ:NYXH), documenting effectiveness and safety in routine practice could help physicians **** s how that design fits their patients' needs.
Longer follow-up could also strengthen the evidence available to payers. Nyxoah SA (NASDAQ:NYXH) could use sustained responses and safety findings to support coverage discussions, while participating centers gain practical experience with implantation and follow-up. That would make BREATHE valuable beyond a single headline response rate.

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