The first patient in the United States has been successfully implanted with a Genio System in a Nyxoah SA clinical trial. The implantation, part of Nyxoah’s DREAM US pivotal Food and Drug Adminstration study, took place at the Nose and Sinus Institute Boca Raton, Fla, and was performed by Melyssa Hancock, MD, otolaryngology-head & neck surgeon.
Hancock says in a release, “We are very excited to be chosen as the first center in the United States to implant the Genio system in a patient for treatment of obstructive sleep apnea. The teaming of the Nose and Sinus Institute of Boca Raton with the innovators at Nyxoah represents the collaboration of some of the most experienced surgeons in the United States today treating nose and airway issues with a team of brilliant international engineers. During this time of COVID-19 and virtual adaptation to everything we do, the fact that we were able to communicate in real-time during the procedure with other surgeons globally who have extensive experience with this device made it a truly extraordinary and successful endeavor.”
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.