Nyxoah SA
NASDAQ:NYXH
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Nyxoah SA
NASDAQ:NYXH
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Nyxoah SA
Nyxoah SA engages in the research and development, manufacture and sale of medical devices. The company is headquartered in Mont-Saint-Guibert, Brabant-Wallon and currently employs 72 full-time employees. The company went IPO on 2020-09-18. The firm focuses on the development and commercialization of solutions and services to treat sleep-disordered breathing conditions. The system consists of a neurostimulator, which is implanted close to the nerve of the tongue, as well as an activation chip, which is connected to a disposable patch and is positioned every night by the patient under the chin.
Nyxoah SA engages in the research and development, manufacture and sale of medical devices. The company is headquartered in Mont-Saint-Guibert, Brabant-Wallon and currently employs 72 full-time employees. The company went IPO on 2020-09-18. The firm focuses on the development and commercialization of solutions and services to treat sleep-disordered breathing conditions. The system consists of a neurostimulator, which is implanted close to the nerve of the tongue, as well as an activation chip, which is connected to a disposable patch and is positioned every night by the patient under the chin.
U.S. launch: Genio launched in the U.S. after FDA approval on August 8, 2025; Q4 U.S. net revenue was approximately EUR 3.5 million and contributed to global momentum.
Commercial footprint: As of Dec 31, 2025 Nyxoah covered 125 of the top 400 HGNS accounts with 25 reps, trained 145 surgeons, submitted 120 VACs and received 57 approvals; sales force expanded to 40 reps in Q1 2026 to cover ~200 accounts.
Reimbursement clarity: CMS issued interim C-codes for HGNS; C-code 8011 (Genio) facility reimbursement set at $31,526 for hospital outpatient, and Genio saw reimbursement from commercial payers (~90% of Q4 business) and Medicare (~10%).
Financials: Q4 2025 net revenue EUR 5.6 million (gross revenue EUR 6.3 million before EUR 0.7 million deferrals); full-year 2025 net revenue EUR 10 million (gross EUR 11 million before EUR 1 million deferrals).
Profitability & cash: Q4 gross margin 64% and full-year 2025 gross margin 63%; full-year operating loss EUR 83.5 million (vs EUR 58.8 million in 2024); cash, cash equivalents and financial assets EUR 48 million at Dec 31, 2025; near-term cash burn ~EUR 20 million per quarter.
Guidance: Management expects U.S. net revenue to grow 25% sequentially in both Q1 and Q2 2026 and expects gross margin to increase slightly through 2026 with a larger step improvement in 2027 after a next-generation disposable patch (Genio 2.2).
Clinical & roadmap: 12-month ACCESS study data due by end of June 2026 with analysis by end of July and a planned PMA supplement submission targeting possible U.S. label expansion in early 2027.
