Nyxoah's Q2 2025: Unpacking Key Contradictions in Commercial Launch, Reimbursement, and Regulatory Strategies

Commercial launch progression, reimbursement strategy and timeline, regulatory approval timeline, reimbursement strategy and code optimization, and commercialization strategy for the U.S. are the key contradictions discussed in Nyxoah's latest 2025Q2 earnings call.



FDA Approval and U.S. Market Entry:
- Nyxoah SA received FDA PMA approval for its GENIOR system, marking the beginning of its U.S. market entry.
- This approval confirms the safety and effectiveness of the innovative technology, authorizing commercial distribution in the U.S.

Revenue and Financial Performance:
- Nyxoah reported revenue of €1,300,000 in Q2 2025, compared to €800,000 in Q2 2024, indicating a 73.8% increase.
- The revenue growth reflects the company's strategic investments and preparations for its post-FDA commercial launch in the U.S.

Investment in U.S. Commercialization:
- Nyxoah's total operating loss increased to $19,900,000 in Q2 2025, up from $13,300,000 in the previous year.
- This increase is attributed to accelerated commercial investments in the U.S. in anticipation of the post-FDA commercial launch.

Laboratory and Reimbursement Strategy:
- Nyxoah plans to use the CPT code 64568 for its GENIOR system, which is recognized by commercial and government payers for OSA indications.
- The company is engaged in the FDA's early payer feedback program and working with the American Academy of Otolaryngology to educate CMS and major commercial payers, aiming for favorable coverage decisions.