Nyxoah (NASDAQ:NYXH) reported third-quarter 2026 revenue of EUR 9.2 million, up 365% from a year earlier, as sales of its Genio sleep apnea therapy in the United States rose 29% from the prior quarter.
The company reiterated its revised full-year revenue forecast of EUR 33 million to EUR 35 million, which it announced on October 19. President and CEO Liam Kelly said the updated outlook reflects U.S. sales more consistent with historical adoption rates for new technologies as physicians and treatment centers gain experience with Genio.
“While we are disappointed to adjust our guidance, we are proud of the strong start to our commercial launch and acceleration in growth,” Kelly said on his first earnings call as CEO.
U.S. Launch Drives Revenue Growth
U.S. net revenue was EUR 6.7 million in the third quarter, compared with 22% sequential growth in the second quarter. International revenue was EUR 2.5 million, up 42% from the third quarter of 2025. Global revenue rose 19% sequentially.
Nyxoah trained 80 surgeons on Genio during the quarter, bringing the total to 342. It also activated 53 accounts, ending the period with 233 active accounts. The company had 447 patients actively undergoing prior authorization through its Genio access program entering the fourth quarter.
Kelly said Nyxoah has 55 sales representatives and will continue adding accounts and training surgeons, while focusing on increasing use of Genio at existing accounts. He identified the U.S. launch as the company’s top priority and primary growth driver.
Asked about expectations for 2027, Kelly declined to provide a forecast, saying the company would issue guidance when it reports fourth-quarter results. He said Nyxoah would focus on execution in the U.S. while maintaining international growth.
FDA Review and Reimbursement
Nyxoah has submitted a premarket approval supplement to the U.S. Food and Drug Administration seeking to expand Genio’s indication to patients with complete concentric collapse, or CCC. The company said those patients account for about one in four people evaluated for hypoglossal nerve stimulation therapy and currently have no such treatment option in the United States.
In September, Nyxoah said its ACCCESS pivotal study met its primary efficacy and safety endpoints in CCC patients. At 12 months, the Apnea-Hypopnea Index responder rate was 77.2%, while the oxygen desaturation index responder rate was 87.7%. The company reported no device- or procedure-related serious adverse events.
Kelly said approval of the expanded indication could broaden the patient population and streamline the treatment process. Genio has been approved for CCC patients in Europe since 2021, he added.
The company also cited increases in 2027 U.S. Medicare facility reimbursement for the Genio procedure. Hospital outpatient reimbursement will rise to $35,072 from $31,526, while ambulatory surgical center reimbursement will increase to $31,283 from $27,563, Kelly said.
Margins Improve as Loss Narrows
Third-quarter gross margin increased to 63.1% from 60.5% a year earlier. Interim Chief Financial Officer Loïc Moreau attributed the improvement to spreading the cost of goods sold over a higher volume of devices. Nyxoah expects full-year gross margin of 60% to 62%.
The company’s operating loss narrowed to EUR 21.9 million from EUR 24.4 million in the prior-year quarter. Cash, cash equivalents and financial assets totaled EUR 77.1 million at September 30, down from EUR 97.8 million at June 30.
Moreau said Nyxoah is shifting spending away from clinical work and research and development toward commercial infrastructure, while seeking to reduce cash burn quarter over quarter.
About Nyxoah (NASDAQ:NYXH)
Nyxoah SA is a medical technology company focused on developing and commercializing solutions for obstructive sleep apnea (OSA), a common sleep-related breathing disorder. The company is headquartered in Mont-Saint-Guibert, Belgium, and its shares trade on the Nasdaq under the symbol NYXH.
Nyxoah’s principal product is the Genio system, an implantable, rechargeable device designed to treat OSA through hypoglossal nerve stimulation. The system is intended to help maintain an open airway during sleep by stimulating the nerves that control the tongue and related upper-airway muscles.
