Nyxoah SA announced the successful first two implantations of its Genio system in the Benelux region of Europe.
The procedures were performed at the Antwerp University Hospital (UZA) in Belgium and were led by internationally ENT surgeon Olivier Vanderveken, MD, PhD.
Vanderveken says in a release, “I am excited to have led the very first implantations of this unique therapy in Benelux. OSA is a very serious condition which, if left untreated, can lead to severe co-morbidities and even death. There are many patients in need of alternative therapeutic solutions to the conventional continuous positive airway pressure (CPAP) therapy and my team at UZA is a leader in this field. The Genio system is minimally invasive, involving just one incision in the chin area, and doesn’t require tunneling, long leads or an internal battery. Moreover, thanks to its unique design and features, the Genio system offers bilateral stimulation of the hypoglossal nerve branches, which may lead to a potentially greater airway opening. I am looking forward to continuing to work with Nyxoah to bring this much needed innovation to more patients suffering from moderate to severe OSA in Belgium and internationally.”
Olivier Taelman, CEO of Nyxoah, says, “We are delighted to have introduced the Genio system in Nyxoah’s home country. This is a key milestone for Nyxoah as we continue to accelerate our efforts to bring this disruptive solution to the market and address a significant current unmet medical need. This, and further implantations in Belgium, will also add to Nyxoah’s body of data as we develop long-term clinical evidence on the Genio system, prepare for the IDE pivotal trial in the United States and accelerate the ongoing market access and commercialisation activities.”
The Genio system received its European CE Mark in March 2019. The company is currently conducting the Better Sleep study in Australia and New Zealand for therapy indication expansion, and a post-marketing EliSA study in Europe to confirm the long-term safety and efficacy of the Genio system. The IDE pivotal study to prepare for US market entrance is currently in discussion with the FDA.