REG-Nyxoah Announces Preliminary Results for the Third Quarter of 2026 and Adjusts Revenue Guidance for 2026
Globe Newswire•19/10/2026•08:00 ET
0
Key Highlights
- ➤2026 revenue guidance cut to €33 million–€35 million from €36 million–€40 million
- ➤Q3 global preliminary net revenue approximately €9.2 million, up 19% sequentially
- ➤U.S. Q3 preliminary net revenue approximately €6.7 million, up 29% sequentially
- ➤FDA PMA supplement submitted to expand Genio indication to CCC patients
- ➤ACCCESS study delivered 77.2% 12-month AHI responder rate with zero serious adverse events
Expert Statements
Liam Kelly, Chief Executive Officer of Nyxoah
“We delivered 29% sequential revenue growth in the U.S. in the third quarter, and our International business performed in line with our expectations.”
Liam Kelly, Chief Executive Officer of Nyxoah
“While we are disappointed to adjust our full year revenue guidance to €33 to €35 million, we are still pleased with the acceleration in growth.”
Liam Kelly, Chief Executive Officer of Nyxoah
“We continue to expect improving U.S. growth in Q4 compared to Q3 2026.”
Liam Kelly, Chief Executive Officer of Nyxoah
“The ramp in U.S. sales is more reflective of historical ramps for a new technology, as physicians and centers build experience with Genio.”
Liam Kelly, Chief Executive Officer of Nyxoah
“Our foundations are strong.”
Liam Kelly, Chief Executive Officer of Nyxoah
“Physicians and OSA patients want a choice in hypoglossal nerve stimulation therapy.”
Liam Kelly, Chief Executive Officer of Nyxoah
“We see this demand in the growing number of active accounts and trained surgeons in the U.S., and in the positive feedback we receive on the Genio system.”
Liam Kelly, Chief Executive Officer of Nyxoah
“We remain confident in our ability to drive durable growth in the U.S. and to improve care for OSA patients.”
Nyxoah Announces Preliminary Results for the Third Quarter of 2026 and Adjusts Revenue Guidance for 2026
U.S. net revenue grows 29% sequentially, driving third quarter global preliminary net revenue of €9.2 million PMA supplement submitted to the FDA to expand Genio’s U.S. indication to Complete Concentric Collapse patients
Get started
Create a free account to read the full story.