Business
Nyxoah Receives Approval from FDA for Genio® System for the Treatment of Obstructive Sleep Apnea
INSIDE INFORMATIONREGULATED INFORMATION Nyxoah Receives Approval from FDA for Genio® System for the Treatment of Obstructive Sleep ApneaU.S. Commercialization Officially Launched Mont-Saint-Guibert, Belgium – August 8, 2025, 10:10pm CET / 4:10pm 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 that the U.S. Food and
About this update from Nyxoah Sa
[{"type":"image","alt":"Nyxoah","displaySize":"","headline":null,"caption":"Nyxoah","className":"","disableSlideshowImg":false,"size":{"original":{"width":300,"height":103,"url":"https://media.zenfs.com/en/globenewswire.com/e7e3b117995786ca545ccd418ff4f6d2"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/tAkvChng_2zCp_EwJSkW7w--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTE0NDtjZj13ZWJw/https://media.zenfs.com/en/globenewswire.com/e7e3b117995786ca545ccd418ff4f6d2","width":300,"height":103}},"lazy":false},{"type":"text","content":"INSIDE INFORMATIONREGULATED INFORMATION","length":40,"tagName":"p"},{"type":"text","content":"Nyxoah Receives Approval from FDA for Genio® System for the Treatment of Obstructive Sleep ApneaU.S. Commercialization Officially Launched ","length":139,"tagName":"p"},{"type":"text","content":"Mont-Saint-Guibert, Belgium – August 8, 2025, 10:10pm CET / 4:10pm 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 that the U.S. Food and Drug Administration (FDA) has approved the Genio system for a subset of patients with moderate to severe OSA with an Apnea-Hypopnea Index (AHI) of greater than or equal to 15 and less than or equal to 65.","length":525,"tagName":"p"},{"type":"text","content":"Genio is a different approach to hypoglossal nerve stimulation (HGNS) for the treatment of OSA. Genio’s unique design utilizes bilateral stimulation, and offers patients a leadless, full-body 1.5T and 3T MRI compatible, non-implanted battery solution, powered and controlled by a wearable component. The wearable component is fully upgradable, providing Genio patients with access to this technology without requiring additional surgeries for technology updates or battery replacements.","length":486,"tagName":"p"},{"type":"text","content":""Today marks a defining moment for Nyxoah and for U.S. patients suffering from OSA. With the FDA’s marketing approval of the Genio system, we are proud to bring this innovative therapy to the U.S. market,” commented Olivier Taelman, Nyxoah’s Chief Executive Officer. “Our mission has always been to make sleep simple for OSA patients by offering them a solution that empowers better sleep. We look forward to the successful execution of our U.S. com...