Core Insights - Nyxoah has announced the commercial launch of its Genio system in England, with successful implants performed at University College London Hospitals (UCLH) [1][3] - The Genio system is now covered under the NHS Specialised Services Devices Programme (SSDP), facilitating access to innovative therapies [2] - The Genio device is a battery-free hypoglossal neuromodulation system designed to treat Obstructive Sleep Apnea (OSA) [4] Company Overview - Nyxoah is focused on developing breakthrough treatment alternatives for OSA through neuromodulation, aiming to address the needs of the billion people suffering from this condition [4] - The Genio system received its European CE Mark in 2019 following the successful completion of the BLAST OSA study [5] - Nyxoah has completed two successful IPOs, one on Euronext Brussels in September 2020 and another on NASDAQ in July 2021 [5] Clinical Milestones - The first two patients were implanted with the Genio system by Mr. Ryan Chin Taw Cheong at UCLH, marking a significant milestone for the company [3] - The company has received CE mark approval for expanding therapeutic indications to include Complete Concentric Collapse (CCC) patients, which are currently contraindicated in competitors' therapies [5] - Positive outcomes from the DREAM IDE pivotal study have been announced, supporting FDA and U.S. commercialization approval [5]
Nyxoah Announces Commercial Launch of Genio® Innovative Therapy in England