Nyxoah(NYXH 5.63%) reported second quarter 2025 earnings on August 18, 2025, highlighting FDA Pre-Market Approval (PMA) for its GENEO system, revenue grew 73.8% year-over-year to €1.3 million, and active steps toward full-scale commercialization in the U.S. The company invested significantly in commercial infrastructure, ending June with €43 million in cash and access to an additional €27.5 million from a term debt facility, while reporting a €19.9 million operating loss, with the increase driven by commercial investments in the U.S. ahead of the post-FDA commercial launch. The call detailed strategic differentiators, reimbursement progress, and timelines for expanding patient eligibility and product labeling, setting the stage for accelerated market penetration.
Nyxoah secures FDA approval and U.S. launch
The GENEO system is now the first and only bilateral hypoglossal nerve stimulation (AGNS) therapy approved in the U.S. for obstructive sleep apnea (OSA), positioning the company as a direct competitor to Inspire Medical. Nyxoah immediately launched with a commercial team of 50 professionals, targeting over 350 high-volume U.S. implanting accounts, representing 75%-80% of market revenue.
"I'm extremely proud to announce that we received FDA PMA approval for our GENEO system in the United States. This result was the culmination of persistence, strong regulatory, and clinical execution supported by the entire passionate and committed Nyxoah S.A. team. For US patients suffering from obstructive sleep apnea or OSA, the GENEO system provides them with a significant advance from currently available treatment options. For physicians, they now have a choice to select the optimal AGNS therapy for their patients. For Nyxoah S.A, it marks the beginning of an exciting journey in the US. This PMA approval confirms the safety and effectiveness of our innovative technology and authorized commercial distribution in the US, which now has actively begun."
-- Olivier Taelman, Chief Executive Officer
The approval unlocks immediate revenue opportunities in the largest global market, making commercial traction and differentiation versus the incumbent critical to the long-term growth thesis.
GENEO system achieves early commercial and clinical milestones
Nyxoah reported that over 100 U.S. physicians are already trained, with additional weekly sessions scheduled, and received initial value analysis committee (VAC) and payer pre-authorization approvals in the first week of U.S. commercialization. The company highlighted 85.9% device compliance, and 90% patient satisfaction rates published in the DREAM study.
"Immediately, upon receiving FDA approval, we started our focused US launch with a commercial organization with over 50 highly talented and experienced professionals. This team is now executing on our two-pronged launch strategy. They will target high volume hypoglossal nerve stimulation implanting centers, where they will position GENEO as a differentiated option for patients suffering from OSA. And they will focus on developing strong referral networks with physicians managing large populations of moderate to severe OSA patients who quit CPAP but are in need of treatment. Our US sales team is already actively engaging with these targeted sites, working through the value analysis committee and pre-authorization approval processes. From a launch execution perspective, I am very pleased to report that already in the first week, we received several VAC and pre-authorization approvals. It's also very exciting to see multiple physicians with patients lined up who are running quickly to become the first to implant the GENEO commercially in the US."
-- Olivier Taelman, Chief Executive Officer
Rapid channel engagement and immediate sales pipeline formation demonstrate early organizational traction in the market.
Nyxoah targets further indication expansion while managing resource allocation
The company strategically stopped enrollment in its ACCESS study, believing it had enough patients to demonstrate statistical efficacy for treating complete concentric collapse (CCC) OSA; under current U.S. labeling, GENEO is not contraindicated but carries a warning for CCC patients, pending further U.S.-specific clinical evidence. The company expects to submit new data and potentially secure FDA label expansion in late fourth quarter 2026 or early first quarter 2027 (calendar), while maintaining strict adherence to on-label promotion and focused indication targeting.
"So when it comes to the access trial, now we stop the enrollment. So the time clock for twelve months can start. So twelve months from now, we will have the data of all access patients, and then based on this study data, we will submit the PMA supplement. Normally, this takes roughly another six months before FDA grants you a supplement. So if you do the math, earliest end of Q4 2026 beginning Q1 2027, we could have CCC patients added to the label. Today, having no contraindications, I will vary I thought that FDA is recognizing already that CCC, it's something where they would like to see US specific data before adding the label. But where they also recognize the fact that CCC should not be a contraindication. And I think that's an important first step in the direction in opening it up in the US market for patients also OSA patients suffering from CCC."
-- Olivier Taelman, Chief Executive Officer
This signals disciplined execution and provides a potential future growth lever once data supports formal label expansion.
Looking Ahead
No explicit implant or revenue forecasts for year-end 2025 were provided. Coverage decisions by major U.S. payers are expected to materialize starting in 2026, while coverage for CCC OSA patients could be added to the label by the end of fourth quarter 2026 or the beginning of first quarter 2027 (calendar), subject to clinical readout and successful FDA supplement approval. No concrete forward guidance on revenue, implant numbers, or margin trajectory was provided.
