Nyxoah Announces Commercial Launch of Genio® Innovative Therapy in England
Nyxoah has launched its Genio system commercially in England, with the first successful implants performed at University College London Hospitals (UCLH). The system, which treats Obstructive Sleep Apnea (OSA) through neuromodulation, is now covered under the NHS Specialised Services Devices Programme (SSDP). The first two patients received their implants from Mr. Ryan Chin Taw Cheong, Consultant ENT and Sleep Surgeon at UCLH. This launch marks a significant expansion of Nyxoah's innovative OSA treatment in the UK healthcare market.
Nyxoah ha lanciato commercialmente il suo Genio system in Inghilterra, con i primi impianti effettuati con successo presso gli University College London Hospitals (UCLH). Il sistema, che tratta l'Apnea Ostruttiva del Sonno (OSA) attraverso la neuromodulazione, è ora coperto dal Programma Dispositivi Servizi Specializzati del NHS (SSDP). I primi due pazienti hanno ricevuto i loro impianti dal dott. Ryan Chin Taw Cheong, Specialista in Otorinolaringoiatria e Chirurgo del Sonno presso gli UCLH. Questo lancio segna un'espansione significativa del trattamento innovativo di OSA di Nyxoah nel mercato sanitario del Regno Unito.
Nyxoah ha lanzado comercialmente su sistema Genio en Inglaterra, con los primeros implantes realizados con éxito en los Hospitales Universitarios de Londres (UCLH). El sistema, que trata la Apnea Obstructiva del Sueño (OSA) a través de la neuromodulación, ahora está cubierto por el Programa de Dispositivos de Servicios Especializados del NHS (SSDP). Los primeros dos pacientes recibieron sus implantes del Dr. Ryan Chin Taw Cheong, Consultor en Otorrinolaringología y Cirujano del Sueño en UCLH. Este lanzamiento marca una expansión significativa del tratamiento innovador de la OSA de Nyxoah en el mercado de atención médica del Reino Unido.
Nyxoah는 영국에서 상업적으로 Genio system을 출시했으며, 런던 대학교 병원(UCLH)에서 성공적으로 첫 번째 임플란트를 시행했습니다. 이 시스템은 폐쇄성 수면무호흡증(OSA)을 신경조절을 통해 치료하며, 현재 NHS 전문 서비스 장치 프로그램(SSDP)으로 보장됩니다. 첫 두 명의 환자는 UCLH의 이비인후과 및 수면 외과 전문의인 라이언 친 타우 청(Ryan Chin Taw Cheong) 박사로부터 임플란트를 받았습니다. 이번 출시는 영국 헬스케어 시장에서 Nyxoah의 혁신적인 OSA 치료의 중요한 확장을 의미합니다.
Nyxoah a lancé commercialement son système Genio en Angleterre, avec les premiers implants réussis réalisés à l'Hôpital Universitaire de Londres (UCLH). Ce système, qui traite l'Apnée Obstructive du Sommeil (OSA) par neuromodulation, est désormais couvert par le Programme de Dispositifs de Services Spécialisés du NHS (SSDP). Les deux premiers patients ont reçu leurs implants du Dr. Ryan Chin Taw Cheong, Consultant en ORL et Chirurgien du Sommeil à l'UCLH. Ce lancement marque une expansion significative du traitement innovant de l'OSA par Nyxoah sur le marché de la santé au Royaume-Uni.
Nyxoah hat sein Genio System kommerziell in England eingeführt, mit den ersten erfolgreichen Implantationen an den University College London Hospitals (UCLH). Das System, das obstruktive Schlafapnoe (OSA) durch Neuromodulation behandelt, ist nun im Rahmen des NHS Programms für spezialisierte Dienstgeräte (SSDP) abgedeckt. Die ersten beiden Patienten erhielten ihre Implantate von Mr. Ryan Chin Taw Cheong, Facharzt für HNO-Heilkunde und Schlafchirurgie am UCLH. Dieser Launch markiert eine signifikante Expansion der innovativen OSA-Behandlung von Nyxoah im britischen Gesundheitsmarkt.
- Commercial launch in England expands market presence
- NHS coverage through SSDP program ensures payment pathway
- First successful implants demonstrate market entry execution
- None.
Insights
The commercial launch of Genio in England marks a significant milestone for Nyxoah's market expansion strategy. Coverage under the NHS Specialised Services Devices Programme is particularly noteworthy, as it provides a clear reimbursement pathway and validates the technology's clinical value. The UK market represents a substantial opportunity with an estimated 1.5 million OSA patients and NHS coverage typically leads to broader adoption across specialized centers.
The successful implants at UCLH, a prestigious institution, establish important credibility for Genio in the UK healthcare system. This launch aligns with Nyxoah's broader European commercialization efforts and could accelerate market penetration through the NHS network. The bilateral hypoglossal nerve stimulation approach of Genio offers a competitive advantage in the growing neurostimulation market for OSA treatment.
The NHS SSDP inclusion represents a significant regulatory and reimbursement achievement for Nyxoah. This program is highly selective and typically reserved for innovative therapies showing substantial clinical benefit. The coverage decision streamlines the adoption process across NHS trusts and suggests favorable health technology assessment outcomes. The partnership with UCLH, a leading academic medical center, provides a strong foundation for establishing treatment protocols and training additional UK centers.
This development could accelerate patient access and market penetration, as NHS coverage often influences private healthcare providers and international markets. The structured rollout through specialized centers of excellence aligns with best practices for introducing novel medical technologies.
Nyxoah Announces Commercial Launch of Genio® Innovative Therapy in England
First patients implanted with Genio at UCLH, London
Mont-Saint-Guibert, Belgium – December 13, 2024, 8:05am CET / 2:05am ET – 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 the commercial launch of its Genio system in England, marked by the first successful implants performed at University College London Hospitals (UCLH).
Genio is now covered under the NHS Specialised Services Devices Programme (SSDP), enabling access to innovative therapies through specialized centers of excellence.
The first two patients were successfully implanted by Mr. Ryan Chin Taw Cheong, Consultant ENT and Sleep Surgeon at UCLH. Commenting on the milestone, Mr. Cheong said: “We are proud to be the first hospital in the UK to offer Genio to our OSA patients. Genio is a groundbreaking, clinically proven therapy that addresses the unmet needs of individuals suffering from Obstructive Sleep Apnea.”
Olivier Taelman, CEO of Nyxoah, added: “Today represents an important milestone for Nyxoah as we introduce our Genio neurostimulation solution to treat Obstructive Sleep Apnea in England. Congratulations to Mr. Cheong and his team on this remarkable achievement. We look forward to expanding our collaboration with UCLH and other leading hospitals in England as we continue our mission to make sleep simple for OSA patients.”
About Nyxoah
Nyxoah is reinventing sleep for the billion people that suffer from obstructive sleep apnea (OSA). We are a medical technology company that develops breakthrough treatment alternatives for OSA through neuromodulation. Our first innovation is Genio®, a battery-free hypoglossal neuromodulation device that is inserted through a single incision under the chin and controlled by a wearable. Through our commitment to innovation and clinical evidence, we have shown best-in-class outcomes for reducing OSA burden.
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 FDA and U.S. commercialization approval.
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, reflecting Nyxoah's current expectations and beliefs 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 utility of clinical data in potentially obtaining FDA approval of the Genio® system; and potential receipt of FDA approval and entrance into the U.S. market. 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 Nyxoah’s Annual Report on Form 20-F for the year ended December 31, 2023, filed with the Securities and Exchange Commission (“SEC”) on March 20, 2024, and subsequent reports that Nyxoah 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, Nyxoah 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 Nyxoah 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 UK
Kinfolk Communications
rebecca@wearekinfolk.co.uk
gemma@wearekinfolk.co.uk
In United States
FINN Partners – Glenn Silver
glenn.silver@finnpartners.com
In Belgium/France
Backstage Communication – Gunther De Backer
gunther@backstagecom.be
In International/Germany
MC Services – Anne Hennecke
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