Article content
Nyxoah announces the commercial launch of its innovative treatment Genio® in England
The first patients to have the Genio device implanted At UCLH, London
Article content
Mont Saint Guibert, Belgium – December 13, 2024, 8:05 AM CET / 2:05 AM ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a medical technology company developing advanced treatment alternatives for obstructive sleep apnea (OSA) through neuromodulation, today announced the commercial launch of its Genio system in England, which marked the first implants Successfully performed at University College London Hospitals (UCLH).
Article content
Genio is now covered under the NHS Specialist Services Devices Program (SSDP), providing access to innovative treatments through specialist centers of excellence.
The first two patients were successfully transplanted by Mr Ryan Chen Tao Cheung, Consultant ENT and Sleep Surgeon at UCL. Commenting on this achievement, Mr Cheung said: “We are proud to be the first hospital in the UK to offer Genio to our sleep apnea patients. Genio is a groundbreaking, clinically proven treatment that addresses the unmet needs of individuals with obstructive sleep apnea.
Olivier Thielemann, CEO of Nyxoah, added: “Today marks an important milestone for Nyxoah as we introduce our Genio neurostimulation solution for the treatment of obstructive sleep apnea in England. Congratulations to Mr Cheung and his team on this fantastic 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 Nexoah
Nyxoah is reinventing sleep for the billion people with obstructive sleep apnea (OSA). We are a medical technology company developing advanced treatment alternatives for obstructive sleep apnea (OSA) through neuromodulation. Our first innovation is Genio®, a battery-free sublingual neuromodulation device that is inserted through a single incision under the chin and controlled by a wearable device. Through our commitment to innovation and clinical evidence, we have demonstrated best-in-class results for reducing the burden of sleep apnea.
Article content
Following the successful completion of the BLAST OSA study, the Genio® system received the European CE Mark in 2019. Nyxoah has completed two successful IPOs: on Euronext Brussels in September 2020 and NASDAQ in July 2021. Following the positive results of the BETTER SLEEP study, Nyxoah has obtained CE Mark approval to expand its therapeutic indications to include patients with complete concentric collapse (CCC), which is currently contraindicated in the treatment of Competitors. Additionally, the company announced positive results from the pivotal study of DREAM IDE for FDA approval and commercialization in the United States.
to caution – CE marked since 2019. US investigative agency. US federal law limits it to investigative use in the United States.
Forward-looking statements
Certain statements, beliefs and opinions expressed in this press release are forward-looking and reflect Nyxoah’s current expectations and beliefs regarding the Genio® System; Planned and ongoing clinical studies of the Genio® System; Potential advantages of the Genio® system; Nyxoah’s objectives regarding 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; The possibility of obtaining FDA approval and entering the American 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 financial results and 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 filed by Nyxoah with the Securities and Exchange Commission. Many factors, including, but not limited to, changes in demand, competition and technology, could cause actual events, performance or results to differ materially 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 considered 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 news release, those results or developments may not be indicative of results or developments in future periods. No representations or warranties are made as to the accuracy or fairness of these 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 news release as a result of any change in expectations or any change in events, terms, assumptions or circumstances on which such forward-looking statements are based. -Data based on appearance, unless specifically required by law or regulation. Neither Nyxoah nor its advisors or representatives, nor any of its subsidiaries, officers or employees, warrants that the assumptions underlying these forward-looking statements are free from errors and does not accept any responsibility for the accuracy of future forward-looking statements contained in this press release or the actual occurrence of anticipated developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.
Contacts:
Nixwah
John Landry, CFO
IR@nyxoah.com
For the media
In the United Kingdom
Kinfolk Communications
rebecca@wearekinfolk.co.uk
Gemma@wearekinfolk.co.uk
In the United States
FINN Partners – Glenn Silver
glenn.silver@finnpartners.com
In Belgium/France
Communication behind the scenes – Günter De Backer
gunther@backstagecom.be
In International/Germany
MC Services – Anne Hennecke
nyxoah@mc-services.eu
attached
Share this article in your social network
Comments are closed, but trackbacks and pingbacks are open.