Nyxoah's Genio System Drives 22% Sequential U.S. Revenue Growth in Q2 2026, Secures $110 Million Financing
核心洞察
Nyxoah (搜索) reported U.S. net revenue of €5.2 million in Q2 2026, representing 22% sequential growth over Q1 2026, driven by accelerating commercial momentum for the Genio (搜索) hypoglossal neurostimulation system.
The company secured $110 million in aggregate financing during Q2, ending the quarter with €97.8 million in cash and financial assets to support continued U.S. commercial expansion.
A total of 262 surgeons have been trained and 180 high-volume accounts activated, with 427 patients under prior authorization entering Q3 2026, a 77% increase over the prior quarter.
Nyxoah (搜索) SA reported its second quarter and first half 2026 financial results on August 5, 2026, revealing accelerating U.S. commercial momentum for its Genio (搜索) system, a leadless and battery-free hypoglossal neurostimulation therapy for obstructive sleep apnea (搜索) (OSA). U.S. net revenue reached €5.2 million in the second quarter, marking 22% sequential growth over the first quarter of 2026.
Global net revenue for the second quarter was €7.7 million, representing 21% sequential growth over the prior quarter. For the first half of 2026, global net revenue totaled €14.0 million, compared to €2.4 million in the first half of 2025, reflecting the continued expansion of U.S. commercialization activities following FDA approval in August 2025.
"The doubling of active accounts in Q2 and the strong acceleration of our patient pipeline, demonstrate the growing acceptance and excitement around Genio (搜索) by physicians and patients," said Olivier Taelman, Chief Executive Officer of Nyxoah (搜索). "With a dedicated Genio C-code for Medicare patients and another quarter of 100% prior-authorization approval for commercial and WISeR patients, we are confident that the current reimbursement landscape supports our accelerating U.S. revenue growth."
Commercial Expansion and Reimbursement Landscape
The company's U.S. commercial organization has grown to 40 active sales representatives focused on covering 200 high-volume hypoglossal nerve (搜索) stimulation (HGNS) accounts. During the second quarter, Nyxoah (搜索) trained 55 new surgeons, bringing the total to 262 trained surgeons, and activated 89 new accounts, doubling the active high-volume accounts to 180.
The patient pipeline showed significant acceleration, with 427 patients actively under prior authorization entering the third quarter of 2026, a 77% increase over the number entering the second quarter. The company maintained a 100% approval rate on reviewed prior authorization submissions.
On the reimbursement front, Medicare issued a dedicated C-code (8011) for Genio (搜索), while commercial payers continued reimbursement under existing CPT codes. CMS proposed reimbursement increases for 2027 of 12% in hospital outpatient settings and 15% in ambulatory surgical centers. Upcoming CPT editorial panel meetings are scheduled to involve the AAO-HNS and industry stakeholders in discussions around comprehensive HGNS coding.
Financial Performance
Gross profit for the second quarter of 2026 was €4.6 million, yielding a gross margin of 60%, compared to 63% in the second quarter of 2025. The decrease in gross margin was primarily attributed to a higher mix of U.S. revenue. For the first half of 2026, gross profit reached €8.2 million with a gross margin of 59%.
Research and development expenses decreased to €9.5 million in the second quarter, down from €10.1 million in the prior-year period, driven by reduced product development expenses. Selling, general and administrative expenses rose to €15.6 million from €10.7 million, reflecting the continued build-out of the U.S. commercial organization.
Total operating loss for the second quarter was €20.6 million, compared to €19.9 million in the second quarter of 2025. For the first half of 2026, the operating loss was €41.1 million versus €40.5 million in the prior-year period.
Financing and Cash Position
Nyxoah (搜索) secured $110 million in aggregate financing during the second quarter of 2026. As of June 30, 2026, cash and cash equivalents and financial assets totaled €97.8 million, compared to €48.0 million at December 31, 2025. Taelman noted that the financing "provides the capital needed to further invest in Genio (搜索)'s U.S. commercial organization in the second half of 2026."
Full-Year 2026 Guidance
The company continues to expect worldwide net revenue for the full year 2026 to be in the range of €36 million to €40 million, with gross margin between 60% and 62%. Total operating expenses are now expected to be between €99 million and €102 million, reflecting an approximately €1 million increase due to a one-time share-based compensation expense of approximately €0.9 million associated with the repricing of employee equity incentive arrangements. Non-GAAP cash operating expenses are expected to range from €88 million to €90 million.
Investor Day Highlights
On July 8, 2026, Nyxoah (搜索) hosted an investor day featuring independent perspectives from ENT and sleep physicians who highlighted Genio (搜索)'s differentiated clinical profile and their intent to expand utilization across patient populations. A reimbursement expert group confirmed the strength and durability of long-term HGNS coverage, with Genio well positioned across future coding scenarios.
The Genio (搜索) system, which received European CE Mark in 2019 and FDA approval in August 2025, is a patient-centered, leadless and battery-free hypoglossal neurostimulation therapy designed to treat OSA, a condition associated with increased mortality risk and cardiovascular comorbidities. Notably, Nyxoah (搜索) received CE mark approval for expansion of therapeutic indications to Complete Concentric Collapse (CCC) patients, a population currently contraindicated in competitors' therapy.