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Nyxoah Provides an Update on Expanded Middle East Presence

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Nyxoah (NASDAQ: NYXH), a medical technology company focused on Obstructive Sleep Apnea (OSA) treatment, announced the expansion of its commercial presence in the Middle East. Following the first successful Genio® implant in Abu Dhabi in September 2025, the company has established new centers across Dubai, Kuwait, and Abu Dhabi.

The Genio® system, which is the only leadless, externally powered bilateral hypoglossal nerve stimulation system for treating moderate-to-severe OSA, is now available through partnerships with leading healthcare institutions in these regions. This expansion follows the company's initial Middle East launch earlier in 2025, targeting patients who cannot tolerate CPAP therapy.

["Geographic expansion into multiple Middle East markets", "Successful first Genio implant completed in Abu Dhabi", "Partnerships established with leading healthcare institutions in the region", "Entry into world-class healthcare systems with renowned Key Opinion Leaders"]

Nyxoah (NASDAQ: NYXH), azienda di tecnologia medica focalizzata sul trattamento dell'apnea ostruttiva del sonno (OSA), annuncia l'espansione della sua presenza commerciale nel Medio Oriente. Dopo il primo impianto Genio® riuscito ad Abu Dhabi nel settembre 2025, l'azienda ha istituito nuovi centri a Dubai, Kuwait e Abu Dhabi. Il sistema Genio®, l'unico sistema di stimolazione bilaterale del nervo ipoglosso senza fili, alimentato esternamente, è ora disponibile tramite collaborazioni con importanti istituzioni sanitarie di queste regioni. Questa espansione segue il lancio iniziale nel Medio Oriente già nel 2025, mirato ai pazienti che non tollerano la terapia CPAP.

Nyxoah (NASDAQ: NYXH), empresa de tecnología médica centrada en el tratamiento de la apnea obstructiva del sueño (AOS), anunció la expansión de su presencia comercial en Oriente Medio. Tras el primer implante Genio® exitoso en Abu Dhabi en septiembre de 2025, la compañía estableció nuevos centros en Dubái, Kuwait y Abu Dhabi. El sistema Genio®, que es el único sistema de estimulación bilateral del nervio hipogloso sin cables y alimentado externamente para tratar la AOS de moderada a severa, ya está disponible mediante asociaciones con instituciones sanitarias líderes en estas regiones. Esta expansión sigue al lanzamiento inicial en Oriente Medio a principios de 2025, dirigido a pacientes que no toleran la terapia CPAP.

Nyxoah(NASDAQ: NYXH), 수면무호흡증(OSA) 치료에 초점을 둔 의료기술 회사는 중동 지역에서의 상업적 입지 확장을 발표했습니다. 2025년 9월 아부다비에서 최초 Genio® 이식이 성공한 후, 회사는 두바이, 쿠웨이트, 아부다비에 새로운 센터를 설립했습니다. 리드리스(케이블 없이) 외부 전원으로 작동하는 양측 설하신경 자극 시스템인 Genio® 시스템은 이제 이 지역의 선두적인 의료기관과의 협력을 통해 이용 가능하며, CPAP 치료를 견디지 못하는 환자들을 대상으로 2025년 초 중동 지역 초기 출시를 바탕으로 확장되었습니다.

Nyxoah (NASDAQ : NYXH), entreprise de technologie médicale axée sur le traitement de l’apnée du sommeil obstructive (AOS), annonce l’expansion de sa présence commerciale au Moyen-Orient. À la suite du premier implant Genio® réussi à Abu Dhabi en septembre 2025, la société a ouvert de nouveaux centres à Dubaï, au Koweït et à Abu Dhabi. Le système Genio®, le seul système de stimulation bilatérale du nerf hypo-glosse sans fil et alimenté externement pour traiter l’AOS de modérée à sévère, est désormais disponible grâce à des partenariats avec des institutions de santé de premier plan dans ces régions. Cette expansion fait suite au lancement initial au Moyen-Orient au début de 2025, visant les patients qui ne tolèrent pas le traitement CPAP.

Nyxoah (NASDAQ: NYXH), ein Unternehmen für Medizintechnik, das sich auf die Behandlung von obstruktiver Schlafapnoe (OSA) spezialisiert hat, announced die Erweiterung seiner kommerziellen Präsenz im Nahen Osten. Nach dem ersten erfolgreichen Genio®-Implantat in Abu Dhabi im September 2025 hat das Unternehmen neue Zentren in Dubai, Kuwait und Abu Dhabi etabliert. Das Genio®-System, das einzige kabellose, extern gespeiste bilaterale Hypoglossus-Nervstimmulationssystem zur Behandlung von moderater bis schwerer OSA, ist nun durch Partnerschaften mit führenden Gesundheitsinstitutionen in der Region verfügbar. Diese Expansion folgt dem ursprünglichen Markteintritt im Nahen Osten Anfang 2025, der Patienten anspricht, die CPAP-Therapie nicht vertragen.

أعلنت شركةNyxoah (بورصة ناسداك: NYXH)، وهي شركة تكنولوجيا طبية تركز على علاج توقف التنفس أثناء النوم الانسدادي (OSA)، عن توسيع حضورها التجاري في الشرق الأوسط. عقب أول زراعة Genio® ناجحة في أبوظبي في سبتمبر 2025، أقامت الشركة مراكز جديدة في دبي والكويت وأبوظبي. نظام Genio®، وهو النظام الوحيد للتحفيز العصبي الحنجري عبر الحنجرة ثنائي الجانب بدون أسلاك ويعمل بالطاقة من الخارج لعلاج OSA من المعتدل إلى الشديد، متاح الآن من خلال شراكات مع مؤسسات صحية رائدة في هذه المناطق. تأتي هذه التوسعة بعد الإطلاق الأول في الشرق الأوسط في وقت سابق من 2025، مستهدفة المرضى الذين لا يتحملون علاج CPAP.

Nyxoah(NASDAQ:NYXH)是一家专注于治疗阻塞性睡眠呼吸暂停(OSA)的医疗科技公司,宣布扩大在中东地区的商业布局。继2025年9月在阿布扎比完成的首次Genio®植入手术取得成功之后,公司在迪拜、科威特和阿布扎比建立了新的中心。Genio®系统是唯一的无导线、外部供电的双边舌下神经刺激系统,用于治疗中度至重度OSA,现在通过与这些区域的领先医疗机构的合作提供。此次扩展紧随2025年初在中东的初始上市,面向无法耐受CPAP治疗的患者。

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Insights

Nyxoah's Middle East expansion strengthens commercial footprint for its Genio device, targeting growth in a region with premium healthcare systems.

Nyxoah's expansion into multiple Middle Eastern healthcare centers represents a significant commercial milestone for the company's Genio system. This bilateral hypoglossal nerve stimulation device for OSA has now established presence in Dubai, Kuwait, and Abu Dhabi following the first implantation earlier in 2025. The expansion demonstrates growing market acceptance of their technology in a region known for premium healthcare facilities and influential Key Opinion Leaders.

What makes this development particularly noteworthy is the strategic targeting of the Middle Eastern market, characterized by high-quality healthcare infrastructure and potentially favorable reimbursement environments. The Genio system's unique leadless and externally powered design differentiates it from competitors in the hypoglossal nerve stimulation space, potentially offering advantages in these new markets.

For Nyxoah, this expansion follows their initial regional launch and represents execution of their international commercialization strategy. The Middle East provides an opportunity to build clinical evidence and physician adoption in centers of excellence, which could accelerate broader acceptance. This market development comes at a critical time for Nyxoah as they work to establish Genio as an alternative for moderate-to-severe OSA patients who cannot tolerate CPAP therapy, the current standard of care.

Nyxoah Provides an Update on Expanded Middle East Presence

New Centers in Dubai, Kuwait, and Abu Dhabi Following First Genio® Implant in the Region Earlier in 2025

Mont-Saint-Guibert, Belgium – September 23, 2025, 10:10pm CET / 4:10pm ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH), a medical technology company that develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA), today announced the continued expansion of its commercial footprint in the Middle East, following the first successful Genio® implant in Abu Dhabi in September 2025.

The Middle East is home to world-class healthcare systems, renowned Key Opinion Leaders, and centers of excellence with outstanding facilities. Nyxoah is proud to partner with these institutions spread over Dubai, Kuwait, and Abu Dhabi to broaden access to Genio and improve outcomes for patients living with Obstructive Sleep Apnea who are unable to tolerate CPAP.

Olivier Taelman, Chief Executive Officer of Nyxoah, commented: "The Middle East represents an important and growing market for Nyxoah, and we are delighted to see this momentum since our initial launch in the region earlier this year. Expanding from Dubai into Kuwait and Abu Dhabi allows us to bring the unique, patient-centric Genio solution to more individuals suffering from Obstructive Sleep Apnea. We are grateful to collaborate with leading healthcare institutions and experts in the region, who share our mission to transform the treatment of OSA and make sleep simple for patients worldwide."

With its growing network of centers across the Middle East, Nyxoah continues to deliver on its commitment to expand patient access to Genio, the only leadless, externally powered bilateral hypoglossal nerve stimulation system for the treatment of moderate-to-severe OSA.

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. and Middle East markets; 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.

Contact:

Nyxoah
John Landry, CFO
IR@nyxoah.com

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FAQ

What regions did Nyxoah (NYXH) expand to in the Middle East in 2025?

Nyxoah expanded its presence to Dubai, Kuwait, and Abu Dhabi, with the first Genio implant performed in Abu Dhabi in September 2025.

What is Nyxoah's Genio system used for?

The Genio system is the only leadless, externally powered bilateral hypoglossal nerve stimulation system used to treat moderate-to-severe Obstructive Sleep Apnea (OSA) in patients who cannot tolerate CPAP therapy.

When was the first Genio implant performed in the Middle East?

The first Genio implant in the Middle East was successfully performed in Abu Dhabi in September 2025.

Why is Nyxoah expanding in the Middle East healthcare market?

The Middle East represents an important and growing market for Nyxoah, featuring world-class healthcare systems, renowned Key Opinion Leaders, and centers of excellence with outstanding facilities.

Who can benefit from Nyxoah's Genio system?

The Genio system is designed for patients with moderate-to-severe Obstructive Sleep Apnea (OSA) who are unable to tolerate CPAP therapy.
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