Nyxoah enrols first patient in BREATHE post-approval OSA study

The Belgian medtech has begun a 229-patient, five-year US real-world study of its Genio bilateral hypoglossal nerve stimulator, approved by the FDA

The Biotech Times Editorial Team By The Biotech Times Editorial Team
A healthcare professional wearing blue surgical gown and gloves positions a handheld silver and black medical device on a sterile blue drape, with coiled cables and blurry hospital equipment in a brightly lit operating room.

Nyxoah has implanted the first patient in BREATHE, its US post-approval study of the Genio system for obstructive sleep apnoea (OSA). The procedure was carried out by otolaryngologist Rolando Molina at South Florida ENT Associates, with Edward Mezerhane of PharmaDev Clinical Research Institute serving as site principal investigator in Miami.

The Belgian medical technology company received FDA approval for Genio in August 2025, following positive results from its DREAM IDE pivotal study announced in 2024. BREATHE represents the next phase of its US clinical programme, generating long-term real-world evidence to satisfy the requirements that routinely accompany device approvals.

Study design and endpoints

BREATHE is a multicenter, prospective, single-arm study enrolling up to 229 adults with moderate to severe OSA across as many as 25 US clinical centres. Patients will be followed for up to five years. The co-primary effectiveness endpoints are Apnea-Hypopnea Index and Oxygen Desaturation Index responder rates measured at 12 months. Safety endpoints track device- and procedure-related serious adverse events at 12 months and annually thereafter.

Chief executive Olivier Taelman said BREATHE would document "how the therapy performs in everyday practice, in the hands of both sleep physicians and surgeons, over five years," adding that it represents "the evidence that patients, physicians and payors expect."

The study is notable for its deliberate inclusion of both sleep medicine physicians and ENT surgeons as implanting clinicians, reflecting the cross-specialty nature of OSA care and Nyxoah's intention to demonstrate broad usability beyond specialist surgical centres.

Market context and competitive landscape

The hypoglossal nerve stimulation market has grown considerably since Inspire Medical Systems pioneered upper-airway stimulation and gained FDA approval over a decade ago. Inspire's unilateral stimulation approach requires a sleep study to confirm the absence of complete concentric collapse before implantation. Nyxoah positions Genio as a differentiated bilateral system that does not carry that anatomical contraindication, having received CE mark expansion in Europe for complete concentric collapse patients. Whether that positioning translates into meaningful share capture in the US will depend on the durability of real-world outcomes data and payer coverage decisions, both of which BREATHE is designed to address.

The broader OSA device market is underpinned by substantial unmet need. A large proportion of people diagnosed with moderate to severe OSA either fail to tolerate continuous positive airway pressure therapy or are non-adherent over the long term, creating a persistent pool of candidates for device-based alternatives. Payors and integrated health systems are increasingly scrutinising the cost-effectiveness of implantable neuromodulation devices, and five-year real-world data of the kind BREATHE is designed to generate will be central to coverage and reimbursement negotiations in the US.

Nyxoah is dual-listed on Euronext Brussels and NASDAQ and completed its US IPO in July 2021. The company has not disclosed commercial sales figures for the US market since receiving FDA approval, and investors will be watching both the pace of BREATHE enrolment and any early commercial adoption signals as near-term indicators of US market penetration.

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