Medical technology firm Nyxoah has secured an investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) to carry out the ACCCESS clinical study of its Genio system.
The Genio system is a next-generation neurostimulation solution that has been developed to treat moderate to severe Obstructive Sleep Apnoea (OSA) in adult patients.
It is claimed to be the first battery-free, leadless and single-incision neurostimulator in the world.
The device keeps the upper airway open while the user is asleep by stimulating the hypoglossal nerve bilaterally, allowing individuals to enjoy restful nights.
Previously, the Genio system received Breakthrough Device Designation from the US FDA for the treatment of Complete Concentric Collapse (CCC) patients.
The ACCCESS trial has been designed to assess the use of the Genio system to treat moderate to severe OSA and CCC of the soft palate in adult patients.
Up to 106 participants are planned to be recruited in the trial.
The Apnea-Hypopnea Index (AHI) responder rate according to the Sher criteria and Oxygen Desaturation Index (ODI) responder rate, which will be evaluated at 12 months after implanting the device, are the co-primary efficacy endpoints of the trial.
Nyxoah CEO Olivier Taelman said: “The ACCCESS IDE approval is an important first step to unlocking an enormous patient population, as more than 30% of OSA patients in the US have CCC.
“Nyxoah is the only hypoglossal nerve stimulation (HGNS) company with a positive CCC clinical trial and CCC approval in Europe, and the ACCCESS study further strengthens our leadership position in addressing the needs of these patients.
“Our BETTER SLEEP trial, which enabled Nyxoah to secure a CCC label expansion in Europe and FDA Breakthrough Device Designation, demonstrated that Genio can provide these patients with a minimally invasive solution for their disorder.”
The company expects to begin implanting the Genio system in study participants from the fourth quarter of the year.
The device received its European CE Mark in 2019, after the successful completion of the BLAST OSA study.