Belgium-based medical technology company Nyxoah has commercially launched its Genio system in England to treat Obstructive Sleep Apnea (OSA) through neuromodulation.
Genio is a battery-free hypoglossal neuromodulation device inserted through a single incision under the chin and controlled by a wearable device.
The system is now covered under the UK’s NHS Specialised Services Devices Programme (SSDP) and can be accessed through specialised centres of excellence.
The University College London Hospitals (UCLH) sleep surgeon and ENT consultant Ryan Chin Taw Cheong completed the first implantation of the Genio system in two patients.
Cheong said: “We are proud to be the first hospital in the UK to offer Genio to our OSA patients. Genio is a groundbreaking, clinically proven therapy that addresses the unmet needs of individuals suffering from Obstructive Sleep Apnea.”
Nyxoah CEO Olivier Taelman said: “Today represents an important milestone for Nyxoah as we introduce our Genio neurostimulation solution to treat Obstructive Sleep Apnea in England.
“Congratulations to Mr. Cheong and his team on this remarkable achievement. We look forward to expanding our collaboration with UCLH and other leading hospitals in England as we continue our mission to make sleep simple for OSA patients.”
The Genio system comprises a neurostimulator, activation chip, charger, and sticky patches.
Its compact neurostimulator is implanted under the chin, electrodes are placed in contact with both branches of the hypoglossal nerve to enable bilateral stimulation of the nerve.
The neurostimulator is controlled by an external activation chip that is placed under the chin with an adhesive patch before sleep.
During sleep, stimulation of the hypoglossal nerve causes a small forward movement of the back of the tongue, preventing it from falling back and blocking the upper airway.
In 2019, the Genio system received the CE mark in the European Union (EU), based on positive results from the BLAST OSA clinical trial.
Later, the therapeutic indications were expanded to include Complete Concentric Collapse (CCC) patients, based on positive results from the BETTER SLEEP study. Furthermore, the company announced positive outcomes from the DREAM IDE study in the US, which will be used for FDA approval and US commercialisation.
