Nyxoah Submits Final Module for FDA Approval of Innovative Sleep Apnea Treatment
Nyxoah Submits Final Module for FDA Approval of Innovative Sleep Apnea Treatment
"Nyxoah" or the "Company"), a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA), today announced that the Company submitted the fourth and final module of its Premarket Approval (PMA) application for Genio to the U.S. Food and Drug Administration (FDA).
Nyxoah（或“公司”）是一家醫療技術公司，專注於開發和商業化創新解決方案，以治療阻塞性睡眠呼吸暫停（OSA），今天宣佈該公司向美國食品藥品監督管理局（FDA）提交了Genio的預市場批准（PMA）申請的第四個和最終模塊。
Genio is a different approach to hypoglossal nerve stimulation (HGNS). Genio offers patients a leadless, fully-body MRI compatible, non-implanted battery solution, powered and controlled by a wearable. Thanks to the fully upgradable wearable component, Genio patients can always have access to the most advanced technology without needing another surgery. In March 2024, Nyxoah announced the DREAM U.S. pivotal study data achieved a statistically significant reduction in the co-primary endpoints of 12-month AHI responder rate, per the Sher criteria, and ODI responder rate, both on an intent-to-treat basis, and that Genio is the only HGNS solution to show similar outcomes in supine and non-supine sleep.
Genio是一種不同的下舌神經刺激（HGNS）方法。Genio爲患者提供了一種無導線、完全身體磁共振兼容、非植入式電池解決方案，由可穿戴設備提供電力和控制。得益於可完全升級的可穿戴組件，Genio患者始終可以訪問最先進的技術，而無需進行其他手術。 2024年3月，Nyxoah宣佈，DREAM美國關鍵研究數據在Sher標準下取得了12個月AHI反應者率和ODI反應者率的統計學顯著降低，並且Genio是唯一在仰臥位和非仰臥位睡眠中顯示類似結果的HGNS解決方案。
譯文內容由第三人軟體翻譯。