The US Food and Drug Administration (FDA) has approved Nyxoah SA’s Investigational Device Exemption (IDE) application to allow Nyxoah to commence its pivotal DREAM study of its Genio system to support its approval in the United States. Nyxoah will initiate the DREAM study in the coming months.
“We are delighted with the FDA approval of our IDE application. This is a significant milestone for Nyxoah that allows us to bring forth our plans for the US introduction of the Genio system and further increase our global footprint alongside our existing presence in Europe and Australia,” says Olivier Taelman, CEO of Nyxoah, in a release. “This major step will allow us to give the first US patients suffering from obstructive sleep apnea (OSA) access to Genio therapy under the DREAM study and to provide US physicians with the opportunity to build expertise with our solution. We are excited to partner with the selected DREAM study centers in the US and internationally.”
The DREAM study is a prospective multicenter trial that will enroll 134 moderate to severe OSA patients who failed first line CPAP therapy in approximately 25 centers in the United States and internationally. The study aims to confirm the safety and effectiveness of the Genio system.
The Genio system is a battery-free, leadless, and minimally invasive implanted neurostimulator designed to keep the upper airway open during sleep for certain people with OSA by bilateral stimulation of the hypoglossal nerve. It has been CE marked since 2019, and is limited by US federal law to investigational use.