The first patient has been successfully implanted with a Genio System in a Nyxoah SA clinical trial. The implantation, part of Nyxoah’s DREAM US pivotal FDA study, took place at Hollywood Private Hospital in Perth, Australia, and was performed by Richard Lewis, MBBS, FRACS, head & neck surgeon.
The DREAM (Dual-sided Hypoglossal neRvE stimulAtion for the treatMent of Obstructive Sleep Apnea) study is a pivotal, Investigational Device Exemption trial designed to support the marketing authorization of the Genio system in the United States. This multicenter, prospective, open-label, observational study will enroll 134 patients, who will undergo the implantation procedure in up to 26 centers worldwide including sites in the United States, Germany, Belgium, and Australia.
Lewis, implanting surgeon from Hollywood Private Hospital, says in a release, “ Our center has an extensive historical collaboration with Nyxoah. We took part in the BLAST OSA study that led to CE Mark approval of the Genio system and we are the lead investigator center in the ongoing BETTER SLEEP study testing the effectiveness of hypoglossal nerve stimulation on Complete Concentric Collapse (CCC) patients who are currently excluded from this type of therapy. We are excited to be part of the DREAM IDE pivotal trial together with US and European physicians and are thrilled to build further clinical evidence on the Genio system giving more patients across the globe access to this innovative OSA therapy.“
Olivier Taelman, Nyxoah CEO, says in a release, “The United States are the largest market in the world for the treatment of patients suffering from obstructive sleep apnea. The DREAM study is designed to support the US introduction of the Genio system. Enabling US physicians to build their first experience with the Genio system, combined with the knowledge of other already experienced international surgeons, is supporting Nyxoah’s mission to offer its disruptive therapy to more OSA patients around the world.”