Mont-Saint-Guibert, Belgium – – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH)(“Nyxoah” or the “Company”), a medical technology company focused on developing and commercializing innovative solutions to treat obstructive sleep apnea (OSA), announced today today that the notified body DEKRA has approved the use of by Nyxoah next generation Genio® 2.1 system for patients Europe. As with the recent approval of Genio® 2.1 by the WE FDA for use in DREAM WE An IDE pivotal study, this CE marking relates entirely to the external components of the Genio® system and will be accessible to all patients who have received Genio® implants.
Genio® 2.1 is designed to improve patient comfort and compliance with a new smartphone app and an improved external activation chip. Genio® 2.1 provides patients with daily feedback on therapy usage and the autonomy to adjust stimulation amplitude within preset limits. Physicians can fine-tune the stimulation amplitude to determine the optimal level of comfort for patients without compromising therapy effectiveness. Additional built-in sensors will allow physicians to further tailor therapy stimulation parameters based on patient position and throughout the night.
“Genio® 2.1 embodies the patient-centered design and scalability of the Genio® platform with features that enable greater customization of therapy to meet the needs of each patient,” commented Olivier Taelman, by Nyxoah Chief executive officer. “It is important to note that these additional features are made available without the need for surgery to replace the implantable component. We are excited to launch Genio® 2.1 in Europereinforcing our vision to meet the needs of patients with OSA with and without complete concentric collapse (CCC) and further accelerating market share gains.”
Nyxoah is a medical technology company focused on the development and commercialization of innovative solutions to treat obstructive sleep apnea (OSA). by Nyxoah Leading solution is the Genio® System, a patient-centric, lead-free, battery-free hypoglossal neurostimulation therapy for OSAS, the world’s most prevalent sleep-disordered breathing disorder associated with an increased risk of cardiovascular mortality and comorbidities . Nyxoah is guided by the vision that OSA patients should enjoy restful nights and feel empowered to live their lives to the fullest.
Following the success of the BLAST OSA study, the Genio® system received its European CE marking in 2019. Nyxoah has completed two successful IPOs: on Euronext Brussels in September 2020 and the NASDAQ in July 2021. Following the positive results of the BETTER SLEEP study, Nyxoah has received CE Mark approval for the extension of its therapeutic indications to patients with complete concentric collapse (CCC), currently contraindicated in the treatment of competitors. Additionally, the Company is currently conducting the pivotal DREAM IDE study for marketing approval by the FDA and the United States.