Nyxoah Reports Third Quarter 2026 Financial and Operating Results
Global net revenue was €9.2 million driven by 29% sequential U.S. net revenue growth
PMA supplement submitted to the FDA to expand Genio’s U.S. indication to include Complete Concentric Collapse patients
Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a medical technology company that develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA) through neuromodulation, today reported financial and operating results for the third quarter of 2026.
Q3 2026 Financial and Operating Highlights
- Financials
- Global net revenue for the third quarter of 2026 was €9.2 million, 19% sequential growth over global net revenue for the second quarter of 2026
- U.S. net revenue for the third quarter of 2026 was €6.7 million, 29% sequential growth over U.S. net revenue for the second quarter of 2026
- Leading U.S. commercial indicators
- 80 new surgeons trained in Q3, bringing the total to 342 surgeons trained
- 53 new accounts activated in Q3, bringing the total to 233 active Genio accounts
- 447 patients actively undergoing prior authorization entering Q4
- Clinical and Regulatory
- ACCCESS U.S. pivotal study met its co-primary efficacy endpoints and its safety endpoints in Complete Concentric Collapse (CCC) patients, with a 12-month AHI responder rate of 77.2% (p<0.001) and zero device- and procedure-related serious adverse events
- Submitted a premarket approval (PMA) supplement to the FDA to expand Genio’s U.S. indication to include CCC patients
- Complete 12-month ACCCESS dataset presented at the International Surgical Sleep Society (ISSS) annual meeting, October 15-16, 2026
- U.S. reimbursement
- CMS published its final rule on 2027 facility reimbursement for the Genio procedure
- Hospital outpatient (OPPS) reimbursement under C-code C8011 increases from $31,526 to $35,072, or approximately 11%
- Ambulatory surgical center (ASC) reimbursement increases from $27,563 to $31,283, or approximately 13%
- CMS published its final rule on 2027 facility reimbursement for the Genio procedure
- Liquidity
- As of September 30, 2026, cash, cash equivalents and financial assets amounted to €77.1 million
“We delivered 29% sequential U.S. revenue growth in the third quarter, an acceleration from 22% in the second quarter. Momentum is building as physicians and centers gain experience with Genio. We see this reflected in the growing base of trained surgeons and active accounts in the U.S., and in the positive physician and patient feedback we receive on the Genio system. Our ACCCESS results and our PMA supplement submission could extend Genio to complete concentric collapse patients in the U.S., who have limited treatment options today. We remain confident in our ability to build durable growth in the U.S. and to improve care for OSA patients,” commented Liam Kelly, Nyxoah’s Chief Executive Officer.
Results for the Three Months Ended September 30, 2026
Revenue
Net revenue for the third quarter of 2026 was €9.2 million, compared to €2.0 million in the third quarter of 2025. The increase in net revenue was primarily driven by the continued expansion of U.S. commercialization activities following FDA approval in August 2025, as well as growth in international markets.
Gross Margin
Gross profit for the third quarter of 2026 was €5.8 million driving a gross margin of 63.1%, compared to a gross margin of 60.5% in the third quarter of 2025. The change in gross margin was primarily due to operating leverage on manufacturing-related costs as volumes increase.
Operating Loss
Total operating loss for the third quarter of 2026 was €21.9 million, versus €24.4 million in the third quarter of 2025. The decrease in operating loss reflects higher gross profit and lower research and development expenses as we shift our focus to commercial execution.
Cash Position
Cash, cash equivalents and financial assets totaled €77.1 million at September 30, 2026, compared to €97.8 million at June 30, 2026.
Financial Guidance for the Full Year 2026
- The Company expects global net revenue for the full year 2026 to be in the range of €33 million to €35 million.
- The Company expects gross margin for the full year 2026 to be in the range of 60% to 62%.
About Nyxoah
Nyxoah is a medical technology company focused on the development and commercialization of innovative solutions to treat OSA. Nyxoah’s lead solution is the Genio system, a patient-centered, leadless and battery-free hypoglossal neurostimulation therapy for OSA, the world’s most common sleep disordered breathing condition that is associated with increased mortality risk and cardiovascular comorbidities. Nyxoah is driven by the vision that OSA patients should enjoy restful nights and feel enabled to live their life to its fullest.
Following the successful completion of the BLAST OSA study, the Genio system received its European CE Mark in 2019. Nyxoah completed two successful IPOs: on Euronext Brussels in September 2020 and NASDAQ in July 2021. Following the positive outcomes of the BETTER SLEEP study, Nyxoah received CE mark approval for the expansion of its therapeutic indications to Complete Concentric Collapse (CCC) patients, currently contraindicated in competitors’ therapy. Additionally, the Company announced positive outcomes from the DREAM IDE pivotal study in 2024 and received approval from the FDA in August 2025, with the treatment of CCC patients included in the warning section of our indications for use.
For more information, please visit http://www.nyxoah.com.
Caution – CE marked since 2019. FDA approved in August 2025 as prescription-only device.
