U.S. FDA Approval and Commercial Launch
Genio received FDA approval on August 8, 2025, and Nyxoah executed its first full U.S. commercial quarter in Q4 2025 with an established U.S. commercial team and launch plan.
Strong Revenue Growth
Full-year 2025 net revenue was EUR 10.0 million versus EUR 4.5 million in 2024, representing 122% year-over-year growth; Q4 2025 net revenue was EUR 5.6 million versus EUR 1.3 million in Q4 2024 (approximately +331% YoY).
U.S. Launch Contribution
U.S. commercialization was a primary driver in Q4 2025, contributing approximately EUR 3.5 million of net revenue in the quarter (company also referenced ~$4.5 million of U.S. revenue in Q4 in commentary).
High Gross Margins
Gross margin of 64% in Q4 2025 and 63% for full-year 2025, with management expecting modest margin improvement in 2026 and a step-function improvement toward ~70% after Genio 2.2 and lower disposable patch costs in 2027.
Commercial Traction and Training Metrics
As of Dec 31, 2025, Nyxoah had trained 145 surgeons across 125 targeted high-volume accounts, submitted 120 value analysis committee (VAC) requests and received 57 VAC approvals with no rejections to date.
Reimbursement Progress
Genio secured reimbursement consistency across commercial payers (~90% of business) and Medicare (~10%); CMS established interim C-codes in Feb 2026 and set a hospital outpatient facility fee of $31,526 for the Genio C-code, creating parity with competitor facility reimbursement.
Sales Force Expansion and Account Coverage
Salesforce increased from 25 reps at launch to 40 reps (adding 15 reps and 3 sales directors in Q1 2026), expanding coverage from ~125 to ~200 of the top 400 HGNS accounts and accelerating account outreach.
International and Operational Progress
International markets (notably Germany) continued to contribute revenue and Germany achieved profitability; management is expanding manufacturing to support scale and improve gross margins.
Near-Term Revenue Growth Outlook
Company guidance expects U.S. net revenue to grow ~25% sequentially in both Q1 and Q2 2026, driven by additional surgeon training, VAC approvals and adoption.