Nyxoah's Reimbursement Breakthrough: A Catalyst for U.S. Market Expansion and Revenue Growth

The recent finalization of CMS reimbursement increases for Nyxoah's Genio® therapy marks a pivotal inflection point for the company's U.S. commercial prospects. With a 48% rise in Hospital Outpatient Department (HOPD) reimbursement and a 58% increase in Ambulatory Surgery Center (ASC) facility payments for CPT Code 64568, effective January 1, 2026, the economic incentives for adopting Genio therapy have been significantly amplified. These changes, coupled with Nyxoah's recent FDA approval and first commercial implants in October 2025, position the company to capitalize on a growing obstructive sleep apnea (OSA) market while addressing critical provider economics.

Reimbursement as a Driver of Adoption

The CMS's decision to assign CPT Code 64568 to New Technology Ambulatory Payment Classification (APC) 1580 has directly elevated reimbursement rates to $45,000 for HOPD and $42,373 for ASC settings. This aligns with historical trends where Medicare reimbursement increases under the New Technology Add-on Payment (NTAP) program have spurred adoption. For instance, a 2025 study found that NTAP-designated technologies saw a 134% increase in utilization post-reimbursement. By placing Genio in a similar category, CMS has created a financial framework that reduces provider hesitancy, particularly in ASCs, where the procedure's single-incision nature already aligns with operational efficiency.

The economic rationale for providers is further strengthened by the updated reimbursement rates. For context, the 2025 Medicare physician fee schedule conversion factor was reduced by 2.83%, pressuring traditional reimbursement models. Genio's higher reimbursement, however, offers a counterbalance, enabling hospitals and ASCs to offset procedural costs while maintaining profitability. This is critical in a market where untreated OSA patients incur 2.5 times higher healthcare costs than non-OSA individuals, driven largely by inpatient care. By addressing OSA proactively, Genio not only reduces downstream costs but also enhances provider margins.

Market Dynamics and Competitive Positioning

The U.S. OSA treatment market is projected to grow at a compound annual growth rate (CAGR) of 6.2% from 2024 to 2030, reaching $6.9 billion by 2030. Genio's differentiation-its leadless, battery-free design-positions it to capture a meaningful share of this growth, particularly among CPAP-intolerant patients. Unlike traditional hypoglossal nerve stimulators, Genio's bilateral stimulation and streamlined implantation process reduce procedural complexity and recovery time, making it an attractive option for both providers and patients.

Competitive dynamics further underscore Genio's potential. Inspire's CMS reimbursement for CPT Code 64568 has seen a $10,000 rise in 2026. However, Genio's ASC-friendly model and higher reimbursement rates may allow Nyxoah to outpace Inspire in market penetration. Notably, ASCs typically operate at lower costs than HOPDs, and the 58% reimbursement increase for ASCs could incentivize a shift in procedure volume to these settings, where Genio's efficiency is already optimized.

Financial Implications and Stock Valuation

Nyxoah's recent financial performance highlights its readiness to scale. In Q3 2025, the company reported €2.0 million in revenue, a 56% year-over-year increase, driven by strong physician demand and payer coverage. The first U.S. commercial implants in October 2025, coupled with CMS coverage, have already translated into a 17.2% stock price surge. Analysts project that the 2026 reimbursement increases will further accelerate revenue growth, particularly as Nyxoah expands its trained surgeon base (111 as of October 2025) and prior authorization submissions as detailed in the Q3 report.

However, risks remain. Inspire's patent infringement lawsuit could delay Genio's U.S. commercialization timeline, and reimbursement variability among commercial payers (which cover ~70-75% of Inspire's patient base) may persist for Nyxoah. That said, the company's recent $27 million fundraising and strategic focus on value-based care-where Genio's cost-effectiveness in reducing hospital readmissions is a key differentiator-mitigate these risks.

Conclusion

Nyxoah's reimbursement breakthrough under CMS's 2026 rules represents more than a regulatory win; it is a structural catalyst for scalable U.S. growth. By aligning provider economics with the clinical and economic value of Genio therapy, the company is poised to accelerate adoption in both HOPD and ASC settings. With a growing OSA market, favorable reimbursement trends, and a differentiated product, Nyxoah's stock valuation appears well-supported by fundamentals. Investors should monitor the pace of commercial implantation and the resolution of legal challenges, but the long-term trajectory for Genio remains compelling.