Belgium-based medical technology company Nyxoah has secured the US Food and Drug Administration (FDA) approval for its Genio system.
The Genio system is intended for patients with moderate to severe obstructive sleep apnea (OSA), specifically those with an Apnea-Hypopnea Index between 15 and 65.
It offers a novel approach to hypoglossal nerve stimulation for OSA treatment.
The device features bilateral stimulation and a leadless design, with a wearable component controlling the device.
Compatible with 1.5T and 3T MRI machines, the component is fully upgradable, eliminating the need for additional surgeries for updates or battery replacements.
The FDA approval marks the official launch of the Genio system in the US market.
Nyxoah CEO Olivier Taelman said: “Today marks a defining moment for Nyxoah and for U.S. 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 FDA’s decision was based on data from Nyxoah’s DREAM pivotal trial.
The study showed a 63.5% responder rate for Apnea-Hypopnea Index and a 71.3% responder rate for Oxygen Desaturation Index.
in addition, 82% of participants saw their AHI scores fall below 15, with a median AHI reduction of 70.8%.
The DREAM study highlighted Genio’s effectiveness regardless of sleeping position, a unique aspect among therapies in large clinical studies.
It showed a 66.6% median AHI reduction in the supine position, where airway obstructions usually increase, compared to a 71% reduction in non-supine positions.
The Genio system, Nyxoah’s lead product, has received its European CE Mark in 2019 and was launched in England, last year.
Thomas Jefferson University department of otolaryngology head and neck surgery associate professor Colin Huntley said: “The Genio system’s approval represents a major addition to the treatment options available to physicians treating patients with OSA.
“This unique bilateral stimulation technology has demonstrated consistent efficacy across all sleeping positions, including the challenging supine position, while maintaining an excellent safety profile.”
