Nyxoah SA has initiated its U.S. post-approval BREATHE study with the first patient implanted using the Genio system, a milestone for expanding clinical evidence of its obstructive sleep apnea therapy following FDA approval. The company's shares fell about 8% in the previous trading session despite the news, and are down 64.8% year to date, compared with the industry's 10.8% growth and the S&P 500's 12.2% rise. The BREATHE study, which is Nyxoah's largest prospective Genio study to date, plans to enroll up to 229 patients across as many as 25 U.S. centers, with follow-up for up to five years. The co-primary effectiveness endpoints measure Apnea-Hypopnea Index and Oxygen Desaturation Index responder rates at 12 months, while safety assessments track device- and procedure-related serious adverse events. The first implant was performed by Dr. Rolando Molina of South Florida ENT Associates, with Dr. Edward Mezerhane as principal investigator. The hypoglossal nerve stimulation therapy market was valued at $358.72 million in 2025 and is expected to grow at a CAGR of 12.10% to reach $1.12 billion by 2035, according to Expert Market Research.
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West Pharmaceutical Services IncNyxoahShares fell 8% despite first U.S. Genio implant in BREATHE study, indicating market disappointment.
Globus Medical