Nyxoah Provides Update on FDA Approvable Letter for Genio System
Nyxoah (NYXH) announced an update regarding the FDA approval process for its Genio system, a neuromodulation treatment for Obstructive Sleep Apnea (OSA). The FDA issued an Approvable Letter on March 26, 2025, indicating that the PMA application substantially meets federal requirements.
The FDA has accepted all clinical data demonstrating Genio's safety and effectiveness. Only one item remains before final approval: the validation of a process used with a component at the U.S. manufacturing site. The company expects to complete this validation and potentially receive full PMA approval in the second quarter of 2025.
Nyxoah (NYXH) ha annunciato un aggiornamento riguardante il processo di approvazione da parte della FDA per il suo sistema Genio, un trattamento di neuromodulazione per l'Apnea Ostruttiva del Sonno (OSA). La FDA ha emesso una Lettera di Approvazione il 26 marzo 2025, indicando che la richiesta di PMA soddisfa sostanzialmente i requisiti federali.
La FDA ha accettato tutti i dati clinici che dimostrano la sicurezza e l'efficacia di Genio. Rimane solo un elemento prima dell'approvazione finale: la validazione di un processo utilizzato con un componente presso il sito di produzione negli Stati Uniti. L'azienda prevede di completare questa validazione e di ricevere potenzialmente l'approvazione completa della PMA nel secondo trimestre del 2025.
Nyxoah (NYXH) anunció una actualización sobre el proceso de aprobación de la FDA para su sistema Genio, un tratamiento de neuromodulación para la Apnea Obstructiva del Sueño (OSA). La FDA emitió una Carta de Aprobación el 26 de marzo de 2025, indicando que la solicitud de PMA cumple sustancialmente con los requisitos federales.
La FDA ha aceptado todos los datos clínicos que demuestran la seguridad y efectividad de Genio. Solo queda un elemento antes de la aprobación final: la validación de un proceso utilizado con un componente en el sitio de fabricación en EE. UU. La empresa espera completar esta validación y potencialmente recibir la aprobación completa de PMA en el segundo trimestre de 2025.
Nyxoah (NYXH)은 Genio 시스템에 대한 FDA 승인 프로세스에 대한 업데이트를 발표했습니다. 이는 폐쇄성 수면 무호흡증 (OSA)을 위한 신경 조절 치료법입니다. FDA는 2025년 3월 26일에 승인 가능 통지서를 발급하였으며, 이는 PMA 신청이 연방 요구 사항을 상당히 충족함을 나타냅니다.
FDA는 Genio의 안전성과 효과를 입증하는 모든 임상 데이터를 수용했습니다. 최종 승인을 받기 전에 남은 사항은 미국 제조 사이트의 구성 요소와 관련된 프로세스의 검증입니다. 회사는 이 검증을 완료하고 2025년 2분기 내에 전체 PMA 승인을 받을 것으로 예상하고 있습니다.
Nyxoah (NYXH) a annoncé une mise à jour concernant le processus d'approbation de la FDA pour son système Genio, un traitement de neuromodulation pour l'Apnée Obstructive du Sommeil (OSA). La FDA a émis une Lettre d'Approbation le 26 mars 2025, indiquant que la demande de PMA répond substantiellement aux exigences fédérales.
La FDA a accepté toutes les données cliniques démontrant la sécurité et l'efficacité de Genio. Il ne reste qu'un élément avant l'approbation finale : la validation d'un processus utilisé avec un composant sur le site de fabrication aux États-Unis. L'entreprise s'attend à finaliser cette validation et à potentiellement recevoir l'approbation complète de la PMA au deuxième trimestre de 2025.
Nyxoah (NYXH) hat ein Update zum FDA-Zulassungsverfahren für sein Genio-System angekündigt, eine Neuromodulationsbehandlung für obstruktive Schlafapnoe (OSA). Die FDA hat am 26. März 2025 einen Genehmigungsbrief ausgestellt, der anzeigt, dass der PMA-Antrag die bundesstaatlichen Anforderungen im Wesentlichen erfüllt.
Die FDA hat alle klinischen Daten akzeptiert, die die Sicherheit und Wirksamkeit von Genio belegen. Nur ein Punkt bleibt vor der endgültigen Genehmigung: die Validierung eines Verfahrens, das mit einer Komponente am US-Standort verwendet wird. Das Unternehmen erwartet, diese Validierung abzuschließen und möglicherweise im zweiten Quartal 2025 die vollständige PMA-Zulassung zu erhalten.
- FDA has accepted all clinical data demonstrating Genio's safety and effectiveness
- Only one final manufacturing validation step remains before potential FDA approval
- Company expects PMA approval in Q2 2025
- U.S. market launch delayed pending manufacturing facility validation completion
Insights
Nyxoah's receipt of an FDA Approvable Letter for the Genio system represents a significant regulatory milestone. This designation confirms the FDA has accepted all clinical data demonstrating safety and effectiveness of the device – the most challenging aspects of any PMA application.
The remaining hurdle involves validating a manufacturing process at their U.S. facility, which is typically more procedural than substantive. The FDA's acceptance of clinical data while requiring only manufacturing validation suggests confidence in the core technology's performance.
For context, PMA approvals for novel neuromodulation devices are rigorous, with only
What's particularly notable is that the FDA has already accepted the clinical study results demonstrating safety and effectiveness – this eliminates the highest-risk component of the approval process. Manufacturing validations, while necessary, rarely derail applications at this stage unless significant quality system deficiencies are identified.
This regulatory progress positions Nyxoah to potentially become only the second neurostimulation technology approved for OSA in the U.S. market, providing an alternative treatment pathway for patients who cannot tolerate continuous positive airway pressure (CPAP) therapy.
The impending FDA approval of Nyxoah's Genio system represents a potential commercial inflection point for this
The Genio system's distinctive bilateral hypoglossal nerve stimulation approach offers meaningful differentiation from existing therapies. With the regulatory path now largely cleared except for manufacturing validation, Nyxoah can accelerate commercial readiness for U.S. market entry.
The U.S. approval would complement Nyxoah's existing CE Mark, potentially expanding their total addressable market substantially. For investors, this regulatory milestone reduces a key risk factor, as clinical acceptance has now been established with the FDA.
Securing final approval in Q2 would allow Nyxoah to begin capturing market share in the second half of 2025. The bilateral stimulation approach could create a competitive advantage in patient selection, positioning, and surgical simplicity compared to other neurostimulation options.
This regulatory advancement essentially transforms Nyxoah from a primarily European commercial entity to a global player in the neurostimulation segment of the OSA market, which could fundamentally change their growth trajectory and valuation metrics as they approach U.S. commercialization.
Nyxoah Provides Update on FDA Approvable Letter for Genio System
Expects to meet final FDA requirements for full PMA approval in the second quarter
Mont-Saint-Guibert, Belgium – April 8, 2025, 07:00am CET / 1:00am ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), which develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA) through neuromodulation, today announced an update on the FDA approval process for the Genio system.
On March 26, 2025, the Company announced that the U.S. Food and Drug Administration (FDA) issued an Approvable Letter regarding the Company's Pre-Market Approval (PMA) application for the Genio® system.
The Approvable Letter means that Nyxoah’s application for marketing the device in the United States substantially meets the requirements of the Federal Food, Drug and Cosmetic Act and the FDA’s PMA implementing regulations codified at 21 C.F.R. Part 814, and the FDA will approve the application subject to satisfactory completion of a manufacturing facilities, methods and controls review. FDA has accepted all other data provided with the PMA submission, including most importantly the clinical study that demonstrates the safety and effectiveness of the Genio® system.
Nyxoah is actively addressing one remaining item before FDA approval may be granted which is the validation of one process used with a component of the Genio system at its U.S. manufacturing site. The Company is confident that it will be able to successfully complete this validation in the near term. As such, Nyxoah anticipates that its application could potentially be approved in the second quarter and intends to provide an update on the review process on its first quarter 2025 earnings call to be held in May.
“We are pleased to share that the Approvable Letter from FDA confirms that we are very close to PMA approval,” commented Olivier Taelman, Nyxoah’s Chief Executive Officer. “We believe the final remaining step is completing a process validation at our U.S. manufacturing site – action taken in response to the last set of specific validation questions sent by the FDA – which we are confident we can address swiftly and successfully. We look forward to launching Genio in the U.S. upon receipt of FDA approval.”
About Nyxoah
Nyxoah is a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (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.
For more information, please visit http://www.nyxoah.com/.
Caution – CE marked since 2019. Investigational device in the United States. Limited by U.S. federal law to investigational use in the United States
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; planned and ongoing clinical studies of the Genio® system; the potential advantages of the Genio® system; Nyxoah’s goals with respect to the development, regulatory pathway and potential use of the Genio® system; receipt of FDA approval; satisfactory completion of a manufacturing facilities, methods and controls review, and the anticipated timing of the foregoing; 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. Additionally, 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
IR@nyxoah.com
For Media
In United States
FINN Partners – Alyssa Paldo
alyssa.paldo@finnpartners.com
In International/Germany
MC Services – Anne Hennecke
nyxoah@mc-services.eu
In Belgium/France
Backstage Communication – Gunther De Backer
gunther@backstagecom.be
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