Nyxoah has introduced its Genio neurostimulator, which is intended for obstructive sleep apnoea (OSA) treatment in England, with the first two implants carried out at University College London Hospitals (UCLH).
UCLH consultant ENT and sleep surgeon Ryan Chin Taw Cheong performed the implants.
Genio can be accessible through the NHS Specialised Services Devices Programme (SSDP), which offers therapies at specialised centres.
The battery-free, single-incision, and leadless system represents a solution for adults suffering from moderate to severe OSA. It comprises a neurostimulator, an activation chip, adhesive patches, and a charger.
Implanted under the chin, the neurostimulator's electrodes engage with the hypoglossal nerve, causing a slight forward movement of the tongue during sleep, which helps prevent airway blockage and provides relief for individuals who struggle with conventional positive airway pressure (PAP) therapies.
Genio is specifically tailored for OSA patients with an apnoea-hypopnea index (AHI) of 15 to 65 years, who are not significantly overweight and have had limited success with PAP therapy.
Nyxoah CEO Olivier Taelman said: "Today represents an important milestone for Nyxoah as we introduce our Genio neurostimulation solution to treat obstructive sleep apnoea in England.
"Congratulations to 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."
Following the BLAST OSA study, Genio secured its European CE Mark in 2019.
The BETTER SLEEP study's positive outcomes led to expanded therapeutic indications for complete concentric collapse patients and paved the way for the DREAM IDE pivotal study, which is critical for US Food and Drug Administration (FDA) and US commercialisation approval.
In July 2022, the company obtained an investigational device exemption approval from the FDA to commence the ACCCESS clinical study of the device.
"Nyxoah introduces neurostimulator device for sleep apnoea in England" was originally created and published by Medical Device Network, a GlobalData owned brand.