Nyxoah Begins Obstructive Sleep Apnea Study in the US
Nyxoah has implanted the first US patient in the Genio system's DREAM study. The trial is designed to support marketing authorization for the device in the United States.
Belgian health-technology company Nyxoah announced the successful implantation of the first US patient in its DREAM pivotal IDE study. The procedure took place at the Nose and Sinus Institute in Boca Raton, Florida, and was performed by surgeon Melyssa Hancock.
The DREAM study (Dual-sided Hypoglossal neRvE stimulAtion for the treatMent of Obstructive Sleep Apnea) is a key Investigational Device Exemption (IDE) trial intended to support marketing authorization for the Genio® system in the United States. This multicenter, prospective, open-label, observational study will enroll 134 patients across up to 26 sites globally, including locations in the US, Germany, Belgium, and Australia.
Implanting surgeon Melyssa Hancock described the collaboration with Nyxoah as successful, highlighting the international expertise involved. She also noted the global real-time communication with other experienced surgeons during the procedure.
Nyxoah CEO Olivier Taelman expressed pride in his team for reaching this milestone despite challenges posed by the COVID-19 pandemic. He stated that enabling US physicians to build experience with the Genio system supports the company's timeline for completing patient enrollment in the study by the end of Q2 2021.