The US Food and Drug Administration (FDA) has granted approval to Nyxoah’s Genio system for treating individuals with moderate to severe obstructive sleep apnoea (OSA).
The system is indicated for use in those having an Apnoea-Hypopnea Index (AHI) between 15 and 65.
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Genio’s approach to hypoglossal nerve stimulation (HGNS) sets it apart with its bilateral stimulation capability.
It is a leadless system that is compatible with 1.5T and 3T magnetic resonance imaging (MRI) scans and eliminates the need for an implanted battery.
The Genio system is powered by an upgradable wearable component, allowing patients to benefit from future technological improvements without the need for additional surgical interventions.
Supporting the FDA’s decision was the data from Nyxoah’s DREAM pivotal trial, which met its primary and secondary goals.
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By GlobalDataThe study showed a 63.5% AHI responder rate and a 71.3% Oxygen Desaturation Index responder rate.
The median reduction in AHI was 70.8%, with 82.0% of subjects reducing their AHI to 15 or below.
An essential aspect of the DREAM study was the demonstration of Genio’s efficacy irrespective of sleeping position.
The company noted that this is the sole therapy to show such results in a prospective, multicentre clinical trial, utilising the full-night polysomnography data.
In the DREAM trial, Genio showed a 66.6% median AHI decrease for those sleeping in the supine position, closely matching the 71.0% decrease observed in other sleeping positions.
Nyxoah CEO Olivier Taelman said: “Today marks a defining moment for Nyxoah and for US patients suffering from OSA. With the FDA’s marketing approval of the Genio system, we are proud to bring this innovative therapy to the US market.
“Our mission has always been to make sleep simple for OSA patients by offering them a solution that empowers better sleep. We look forward to the successful execution of our US commercialisation strategy.”
The Genio system received the European CE Mark in 2019 following the BLAST OSA trial.
