דרוג:

טיפולי ה-Genio^® של Nyxoah זוכים להגדלה משמעותית בהחזרי Medicare לשנת 2026 במסגרת תקנות ה-CMS הסופיות

ההקצאה לטכנולוגיה חדשה APC 1580 מהווה חדשות חיוביות עבור הפריסה המסחרית של Nyxoah בארצות הברית על ידי חיזוק הכלכלה של בתי החולים וה-ASC

מון-סן-גיבר (בלגיה), 26 בנובמבר 2025, GLOBE NEWSWIRE –

Nyxoah SA (נאסד"ק/יורונקסט בריסל: NYXH) ("Nyxoah" או "החברה"), חברת טכנולוגיות רפואיות שמתמקדת בפיתוח ומסחור של פתרונות ושירותים חדשניים לדום נשימה בשינה (OSA) באמצעות נוירומודולציה, הודיעה כי המרכזים לשירותי Medicare ו- Medicaid של ארצות הברית (CMS) סיימו לקבוע את התקנות ל-2026 של מערכת התשלומים הצפויים לאשפוז חוץ (HOPPS) ולמרכז הכירורגי האמבולטורי (ASC). במסגרת התקנות הסופיות, CMS הקצה את הקוד CPT 64568, הקוד המשמש לכל שתלי גירוי העצב התת לשוני (HGNS) של Genio, לסיווג התשלומים האמבולטוריים הטכנולוגיים החדש (APC) 1580.

Nyxoah’s Genio® Therapy Receives Significant 2026 Medicare Reimbursement Increases Under Final CMS Rule

Assignment to New Technology APC 1580 is positive news for Nyxoah’s U.S. commercial rollout by strengthening hospital and ASC economics

Mont-Saint-Guibert (Belgium), November 26, 2025, GLOBE NEWSWIRE – 

Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a medical technology company that develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA) through neuromodulation, today announced that the U.S. Centers for Medicare & Medicaid Services (CMS) has finalized its CY2026 Hospital Outpatient Prospective Payment System (HOPPS) and Ambulatory Surgery Center (ASC) Rule. Within the final rule, CMS assigned CPT Code 64568, the code used for all Genio hypoglossal nerve stimulation (HGNS) implants, to New Technology Ambulatory Payment Classification (APC) 1580.

Effective January 1, 2026, Hospital Outpatient Department (HOPD) reimbursement for CPT 64568 will increase to approximately $45,000, a 48% rise compared to 2025. In addition, Ambulatory Surgery Centers (ASC) facility reimbursement will increase to $42,373, reflecting a 58% increase compared to 2025.

These updates apply uniformly to all procedures billed under CPT 64568, including Genio®, and strengthen the economic foundation supporting therapy adoption across U.S. hospital outpatient departments and ambulatory surgical centers. With CMS’ decision, Genio® enters 2026 with a stronger reimbursement framework that is expected to support broader adoption, increased procedural throughput, and expansion across Medicare-heavy institutions.

Genio®’s single-incision procedure is well suited for the ASC environment, and the significant increase in ASC facility payment creates new opportunities for therapy expansion and site-of-service diversification.

“CMS’ decision to significantly increase reimbursement for CPT 64568 reinforces the growing recognition of hypoglossal nerve stimulation as a high-value therapy for obstructive sleep apnea,” commented Olivier Taelman, Nyxoah's Chief Executive Officer.“ The new rates create a more favorable environment for expanding access to our Genio therapy across both outpatient hospitals and ASCs.”

About Nyxoah

Nyxoah is a medical technology company focused on the development and commercialization of innovative solutions to treat OSA. Nyxoah’s lead solution is the Genio system, a patient-centered, leadless and battery-free hypoglossal neurostimulation therapy for OSA, the world’s most common sleep disordered breathing condition that is associated with increased mortality risk and cardiovascular comorbidities. Nyxoah is driven by the vision that OSA patients should enjoy restful nights and feel enabled to live their life to its fullest.

Following the successful completion of the BLAST OSA study, the Genio system received its European CE Mark in 2019. Nyxoah completed two successful IPOs: on Euronext Brussels in September 2020 and NASDAQ in July 2021. Following the positive outcomes of the BETTER SLEEP study, Nyxoah received CE mark approval for the expansion of its therapeutic indications to Complete Concentric Collapse (CCC) patients, currently contraindicated in competitors’ therapy. Additionally, the Company announced positive outcomes from the DREAM IDE pivotal study and receipt of approval from the FDA for a subset of adult patients with moderate to severe OSA with an AHI of greater than or equal to 15 and less than or equal to 65.

For more information, please visit http://www.nyxoah.com/.

Caution – CE marked since 2019. FDA approved in August 2025 as prescription-only device.

Forward-looking statements

Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company’s or, as appropriate, the Company directors’ or managements’ current expectations regarding the Genio system; the potential advantages of the Genio system; Nyxoah’s goals with respect to the potential use of the Genio system; the Company's commercialization strategy and entrance to the U.S. market; and the Company's results of operations, financial condition, liquidity, performance, prospects, growth and strategies. By their nature, forward-looking statements involve a number of risks, uncertainties, assumptions and other factors that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties, assumptions and factors could adversely affect the outcome and financial effects of the plans and events described herein. These risks and uncertainties include, but are not limited to, the risks and uncertainties set forth in the “Risk Factors” section of the Company’s Annual Report on Form 20-F for the year ended December 31, 2024, filed with the Securities and Exchange Commission (“SEC”) on March 20, 2025 and subsequent reports that the Company files with the SEC. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward-looking statements contained in this press release regarding past trends or activities are not guarantees of future performance and should not be taken as a representation that such trends or activities will continue in the future. In addition, even if actual results or developments are consistent with the forward-looking statements contained in this press release, those results or developments may not be indicative of results or developments in future periods. No representations and warranties are made as to the accuracy or fairness of such forward-looking statements. As a result, the Company expressly disclaims any obligation or undertaking to release any updates or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward- looking statements are based, except if specifically required to do so by law or regulation. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person's officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.

Contacts:

Nyxoah
John Landry, CFO
[email protected]

Rémi Renard
Chief Investor Relations & Corporate Communication Officer
[email protected]

Attachment

• ENGLISH_2026 CMS Final Payment Rule_FINAL

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