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Nyxoah Files Patent Infringement Lawsuit Against Inspire Medical Systems, Inc.

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Nyxoah (NASDAQ:NYXH) has filed a patent infringement lawsuit against Inspire Medical Systems in the United States District Court for the District of Delaware. The lawsuit alleges that Inspire's IV and V devices infringe on three of Nyxoah's U.S. patents (8,700,183, 9,415,215, and 9,415,216).

The Company is seeking injunctive relief and damages, while defending its proprietary Genio® system, which features bilateral stimulation, full body MRI compatibility, and an upgradable platform that eliminates the need for battery replacement surgery. CEO Olivier Taelman highlighted positive feedback from the first month of U.S. commercial launch of the Genio system for Obstructive Sleep Apnea (OSA) treatment.

Nyxoah (NASDAQ:NYXH) ha avviato una causa per violazione di brevetti contro Inspire Medical Systems presso il United States District Court per il Distretto del Delaware. La quere la sostiene che i dispositivi IV e V di Inspire violano tre brevetti statunitensi di Nyxoah (8,700,183, 9,415,215 e 9,415,216). L'azienda chiede provvedimenti d'urgenza e danni, difendendo al contempo il proprio sistema Genio®, che offre stimolazione bilaterale, piena compatibilità MRI a livello corporeo e una piattaforma aggiornabile che elimina la necessità di un intervento di sostituzione della batteria. Il CEO Olivier Taelman ha evidenziato feedback positivi dal primo mese di lancio commerciale negli Stati Uniti del sistema Genio per il trattamento dell’apnea ostruttiva del sonno (OSA).

Nyxoah (NASDAQ:NYXH) ha presentado una demanda por infracción de patentes contra Inspire Medical Systems ante la United States District Court del Distrito de Delaware. La demanda sostiene que los dispositivos IV y V de Inspire infringen tres patentes estadounidenses de Nyxoah (8,700,183, 9,415,215 y 9,415,216). La compañía solicita medidas cautelares y daños, mientras defiende su sistema propietario Genio®, que ofrece estimulación bilateral, compatibilidad total con MRI de cuerpo completo y una plataforma actualizable que elimina la necesidad de cirugía de reemplazo de batería. El CEO Olivier Taelman destacó comentarios positivos del primer mes desde el lanzamiento comercial en EE. UU. del sistema Genio para el tratamiento de la apnea obstructiva del sueño (OSA).

Nyxoah(NASDAQ:NYXH)가 미국 델라웨어 주 연방지방법원에서 Inspire Medical Systems를 상대로 특허권 침해 소송을 제기했습니다. 소송에 따르면 Inspire의 IV 및 V 기기가 Nyxoah의 미국 특허 8,700,183, 9,415,215 및 9,415,216 세 건을 침해합니다. 회사는 금지 명령 및 손해배상을 구하는 한편, 양측 자극, 전신 MRI 호환성 및 배터리 교체 수술의 필요성을 없애는 업그레이드 가능한 플랫폼을 갖춘 독자적인 Genio® 시스템을 방어합니다. CEO Olivier Taelman은 OSA 치료를 위한 Genio 시스템의 미국 내 첫 달 상업 출시에서 긍정적 피드백을 강조했습니다.

Nyxoah (NASDAQ:NYXH) a déposé une action en contrefaçon de brevet contre Inspire Medical Systems devant le United States District Court pour le District of Delaware. La plainte affirme que les dispositifs IV et V d’Inspire violent trois brevets américains de Nyxoah (8 700 183, 9 415 215 et 9 415 216). La société sollicite des mesures d’injonction et des dommages-intérêts tout en défendant son système propriétaire Genio®, qui propose une stimulation bilatérale, une compatibilité MRI corporelle complète et une plateforme évolutive qui élimine le besoin d’une chirurgie de remplacement de batterie. Le PDG Olivier Taelman a souligné les retours positifs du premier mois de lancement commercial américain du système Genio pour le traitement de l’apnée obstructive du sommeil (OSA).

Nyxoah (NASDAQ:NYXH) hat eine Patentverletzungsklage gegen Inspire Medical Systems vor dem United States District Court for the District of Delaware eingereicht. Die Klage behauptet, dass Inspire’s IV- und V-Geräte drei US-Patente von Nyxoah (8,700,183, 9,415,215 und 9,415,216) verletzen. Das Unternehmen ersucht um einstweilige Verfügungen und Schadensersatz, während es sein eigenes Genio®-System verteidigt, das bilaterale Stimulation, volle Ganzkörper-MRI-Kompatibilität und eine upgradbare Plattform bietet, die eine Batterieaustausch-OP überflüssig macht. CEO Olivier Taelman hob positives Feedback vom ersten Monat des US-Startups des Genio-Systems zur Behandlung von obstruktiver Schlafapnoe (OSA) hervor.

قدمت Nyxoah (NASDAQ:NYXH) دعوى انتهاك للبراءات ضد Inspire Medical Systems أمام محكمة الولايات المتحدة الدرجة الأولى بمنطقة ديلاوير. تزعم الدعوى أن أجهزة IV وV من Inspire تنتهك ثلاث براءات اختراع أمريكية لـ Nyxoah (8,700,183، 9,415,215 و9,415,216). تطلب الشركة أوامر قضائية زجرية وتعويضات، في حين تدافع عن نظامها المملوك Genio®، الذي يتميز بالتحفيز الثنائي والتوافق الكامل مع التصوير بالرنين المغناطيسي على مستوى الجسم ومنصة قابلة للترقية تقضي على الحاجة لجراء جراحة استبدال البطارية. وأبرز الرئيس التنفيذي أوليفييه تايلمان التعليقات الإيجابية من الشهر الأول لإطلاق Genio في السوق الأمريكية لعلاج انقطاع النفس النومي الانسدادي (OSA).

Nyxoah(纳斯达克股票代码:NYXH)已在美国特拉华州地方法院对 Inspire Medical Systems 提出专利侵权诉讼。诉状称 Inspire 的 IV 及 V 设备侵犯 Nyxoah 的三项美国专利(8,700,183、9,415,215 和 9,415,216)。公司请求禁令与赔偿,同时为其专有的 Genio® 系统辩护,该系统具备双边刺激、全身 MRI 兼容性以及可升级的平台,避免了电池置换手术的需求。CEO 奥利维耶·泰尔曼强调 Genio 系统在美国市场推出的首月对治疗阻塞性睡眠呼吸暂停(OSA)所获得的积极反馈。

Positive
  • Company actively defending intellectual property rights through legal action
  • Genio system offers unique features including bilateral stimulation and full body MRI compatibility
  • Positive initial feedback from U.S. commercial launch of Genio system
Negative
  • Legal proceedings could involve significant costs and resources
  • Patent litigation outcome uncertainty could impact business operations

Nyxoah Files Patent Infringement Lawsuit Against Inspire Medical Systems, Inc.

Mont-Saint-Guibert, Belgium – September 15, 2025, 10:10pm CET / 4:10pm ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) and Nyxoah, Inc. (collectively, “Nyxoah” or the “Company”), a medical technology company that develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA), today announced that it has filed a lawsuit against Inspire Medical Systems, Inc. (“Inspire”) alleging that the Inspire IV and Inspire V devices infringe the following three patents held by the Company; U.S. Patent Nos. 8,700,183, 9,415,215, and 9,415,216. The suit was filed in the United States District Court for the District of Delaware, seeking injunctive relief and damages for infringement.

“We will defend our intellectual property portfolio and the proprietary, minimally invasive Genio® system, which does not rely on traditional pacemaker hardware but is a differentiated solution offering bi-lateral stimulation, full body MRI compatibility and an upgradable technology platform that does not require re-surgery for battery replacements,” said Olivier Taelman, Chief Executive Officer. “At Nyxoah, we remain committed to putting patients first and offering physicians an alternative, trusting them to make the best decision for their patients suffering from OSA. We’re excited about the positive feedback we have received from both physicians and patients in the first month post-US commercial launch and look forward to introducing the Genio system to more physicians and OSA patients so they can choose the best solution for their needs.”

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 U.S. FDA approval of a Premarket Approval application.

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; 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; the Company's commercialization strategy and entrance to the U.S. market; the Company’s intellectual property portfolio; 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, or adverse litigation outcomes 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

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FAQ

What patents is Nyxoah (NYXH) claiming Inspire Medical Systems has infringed?

Nyxoah claims Inspire's IV and V devices infringe on three U.S. patents: No. 8,700,183, 9,415,215, and 9,415,216.

What are the key features of Nyxoah's Genio system for OSA treatment?

The Genio system features bilateral stimulation, full body MRI compatibility, and an upgradable platform that doesn't require re-surgery for battery replacements.

Where has Nyxoah filed its patent infringement lawsuit against Inspire?

Nyxoah filed the lawsuit in the United States District Court for the District of Delaware.

What is Nyxoah seeking in its lawsuit against Inspire Medical Systems?

Nyxoah is seeking injunctive relief and damages for the alleged patent infringement.

How has the U.S. commercial launch of Nyxoah's Genio system been received?

According to CEO Olivier Taelman, the company has received positive feedback from both physicians and patients in the first month post-US commercial launch.
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