REG-Nyxoah Reports Third Quarter 2026 Financial and Operating Results
Globe Newswire•05/11/2026•16:05 ET
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Key Highlights
- ➤Q3 global net revenue €9.2 million, up 19% sequentially
- ➤U.S. net revenue €6.7 million, up 29% sequentially
- ➤2026 revenue guidance €33 million-€35 million; gross margin 60%-62%
- ➤ACCCESS study delivered 77.2% 12-month AHI responder rate in CCC patients
- ➤FDA PMA supplement submitted to expand Genio indication to CCC patients
Expert Statements
Liam Kelly, Chief Executive Officer of Nyxoah
“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.”
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
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