Nyxoah SA reports medical-technology developments tied to the Genio system, its patient-centered, leadless and battery-free hypoglossal neurostimulation therapy for obstructive sleep apnea. Company news commonly covers financial and operating results, U.S. commercialization activity, regulatory status, manufacturing capacity, reimbursement references, investor conference participation, and the development and commercialization of OSA treatment alternatives.
Nyxoah also publishes regulated information for its Euronext Brussels and Nasdaq securities, including transparency notifications, shareholder-meeting materials, voting-right disclosures, and bond-related capital-structure notices.
Nyxoah (NYXH) reported third-quarter 2026 global net revenue of €9.2 million, supported by continued expansion of U.S. commercialization. Revenue rose 19% sequentially; U.S. revenue reached €6.7 million, up 29% from the second quarter. Gross margin increased to 63.1% from 60.5% a year earlier. Net loss narrowed to €17.830 million from €23.580 million.
The ACCCESS study met its efficacy and safety endpoints in patients with complete concentric collapse, a pattern of airway closure. Nyxoah submitted an FDA application supplement to expand Genio’s U.S. indication to these patients; approval remains pending. Cash, cash equivalents and financial assets totaled €77.1 million at September 30, down from €97.8 million at June 30. The company expects full-year revenue of €33 million to €35 million and gross margin of 60% to 62%.
Nyxoah (NYXH) will release its third-quarter 2026 financial results on November 5, 2026, and host a management conference call that day. The call begins at 10:30 pm CET / 4:30 pm ET. A webcast will be accessible through the company’s Investor Relations page, with an archived replay available shortly after the call.
Nyxoah (NYXH) lowered its full-year 2026 revenue outlook while reporting preliminary third-quarter sales growth and progress toward expanding Genio’s U.S. indication. The company now expects annual global net revenue of €33 million to €35 million, versus €36 million to €40 million previously. Preliminary third-quarter global net revenue is expected to be approximately €9.2 million, up 19% sequentially; U.S. revenue is expected to be approximately €6.7 million, up 29%.
The ACCCESS study met its co-primary efficacy and safety endpoints in Complete Concentric Collapse patients, with a 77.2% 12-month apnea-hypopnea index responder rate and zero device- and procedure-related serious adverse events. Nyxoah submitted an FDA approval supplement to expand Genio’s U.S. indication to these patients. Cash, cash equivalents and financial assets are expected to be approximately €77.0 million at September 30, 2026. Financial estimates are unaudited and subject to revision.
Nyxoah (NYXH) presented complete ACCCESS pivotal study results showing a 74.3% median reduction in breathing disruptions with Genio at 12 months. The study evaluated patients with obstructive sleep apnea and complete concentric collapse (CCC) of the soft palate. Both co-primary endpoints were met: responder rates were 77.2% for the Apnea-Hypopnea Index (AHI), measuring breathing disruptions, and 87.7% for the Oxygen Desaturation Index (ODI), measuring oxygen drops, on a Full Analysis Set basis (both p<0.001).
In the per protocol population, mean AHI fell from 33.6 to 10.4 events per hour; mean ODI fell from 32.6 to 10.9. No device- or procedure-related serious adverse events occurred through 12 months; four unrelated serious events were reported. Nyxoah submitted an FDA premarket approval supplement seeking to expand Genio’s indication to CCC patients. Follow-up will continue for three years post-implant.
Nyxoah (NYXH) appointed Liam Kelly chief executive officer effective October 1, 2026, succeeding Olivier Taelman.
Nyxoah links the change to its shift toward U.S.-focused commercialization following FDA approval and the U.S. launch of its Genio sleep apnea treatment. Kelly served as president and CEO of Teleflex (TFX) from January 2018 until January 2026 and as its chairman from May 2020 until January 2026. He is also a director of Enovis (ENOV).
Nyxoah (NYXH) announced that Chief Financial Officer John Landry will step down effective October 2, 2026, and reaffirmed its full-year 2026 financial guidance.
Loïc Moreau, currently President International and former CFO, will assume the role of interim CFO upon Landry’s departure while a search for a permanent successor is conducted. The company continues to expect 2026 worldwide net revenue between €36 million and €40 million, gross margin between 60% and 62%, total operating expenses between €99 million and €102 million, and non-GAAP cash operating expenses between €88 million and €90 million.
Nyxoah develops the Genio hypoglossal neurostimulation system for obstructive sleep apnea, which has held a CE Mark since 2019 and received FDA approval in August 2025 as a prescription-only device.
Nyxoah (NYXH) reported implantation of the first patient in BREATHE, its U.S. post-approval study of the Genio® hypoglossal nerve stimulation system for obstructive sleep apnea.
BREATHE is a multicenter, prospective, single-arm study in adults with moderate to severe OSA, planning to implant up to 229 patients at up to 25 U.S. centers with follow-up for up to five years. Co-primary effectiveness endpoints are Apnea-Hypopnea Index (AHI) and Oxygen Desaturation Index (ODI) responder rates at 12 months, while safety endpoints track device- and procedure-related serious adverse events at 12 months and annually thereafter. The company said BREATHE will build long-term, real-world evidence for Genio in routine clinical practice.
Nyxoah (NYXH) reported that its ACCCESS U.S. pivotal study in Complete Concentric Collapse (CCC) patients met all co-primary safety and efficacy endpoints at 12 months for the Genio hypoglossal nerve stimulation system.
The Full Analysis Set of 47 implanted and activated patients showed an Apnea-Hypopnea Index (AHI) responder rate of 77.2% and an Oxygen Desaturation Index (ODI) responder rate of 87.7%, both statistically significant (p<0.001). No device-related serious adverse events were observed through 12 months post-implant. The trial was conducted under an FDA-approved protocol, using prespecified multiple imputation for missing data. Nyxoah is preparing a premarket approval (PMA) supplement to seek expansion of Genio’s U.S. indication to CCC patients, under FDA Breakthrough Device Designation, with full 12‑month data planned for presentation at the ISSS meeting in October 2026.
Nyxoah (Euronext Brussels & Nasdaq: NYXH) reported updated capital and voting-rights data following the issuance of 1,767,402 new shares on August 20, 2026, linked to a contribution in kind of a receivable held by the holder of its December 18, 2025 convertible bonds.
According to Nyxoah, total share capital now amounts to EUR 7,092,826.33, represented by 101,840,217 ordinary shares, each carrying one voting right. The company also detailed outstanding subscription rights and 225 convertible bonds, including the maximum voting rights that could result from their conversion at specified prices.
Nyxoah (Nasdaq/Euronext: NYXH) reported Q2 2026 net revenue of €7.7 million, up from €1.3 million in Q2 2025, with U.S. net revenue of €5.2 million and 22% sequential U.S. growth. First-half 2026 net revenue reached €14.0 million versus €2.4 million a year earlier.
Q2 2026 gross margin was 60% versus 63% in Q2 2025, and operating loss was €20.6 million; net loss was €33.0 million, or €0.578 per share. The company secured $110 million in aggregate financing, ending June 30, 2026 with €97.8 million in cash, cash equivalents and financial assets. Nyxoah maintained 2026 revenue guidance of €36–40 million and gross margin of 60–62%, but raised total operating expense guidance to €99–102 million, while reiterating non-GAAP cash operating expenses of €88–90 million.