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”）是一家医疗技术公司，专注于开发和商业化创新解决方案，以治疗阻塞性睡眠呼吸暂停（OSA），今天宣布该公司向美国食品药品监督管理局（FDA）提交了Genio的预市场批准（PMA）申请的第四个和最终模块。
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是一种不同的下舌神经刺激（HGNS）方法。Genio为患者提供了一种无导线、完全身体磁共振兼容、非植入式电池解决方案，由可穿戴设备提供电力和控制。得益于可完全升级的可穿戴组件，Genio患者始终可以访问最先进的技术，而无需进行其他手术。 2024年3月，Nyxoah宣布，DREAM美国关键研究数据在Sher标准下取得了12个月AHI反应者率和ODI反应者率的统计学显著降低，并且Genio是唯一在仰卧位和非仰卧位睡眠中显示类似结果的HGNS解决方案。