Medical technology company Nyxoah has commercially launched its Genio system in England for obstructive sleep apnoea (OSA) treatment.
Genio is a battery-free hypoglossal neuromodulation device. The leadless device is inserted through a single incision under the chin and controlled by a wearable.
The system is now covered by the National Health Service (NHS) Specialised Services Devices Programme (SSDP), which provides access to advanced therapies at specialised centres.
Belgium-based Nyxoah has also announced the first successful patient implants at University College London Hospitals (UCLH).
The first two patients were successfully implanted with the Genio system by Ryan Chin Taw Cheong, an ear, nose, throat (ENT) consultant and sleep surgeon at UCLH.
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 Apnoea.”
The Genio system received its European CE mark in 2019 based on the results from the BLAST OSA study.
Following positive results from the BETTER SLEEP study, Nyxoah expanded the system’s therapeutic indications to include complete concentric collapse (CCC) patients, an indication currently contraindicated in competitor therapies.
The medical technology company also announced positive results from the DREAM investigational device exemption (IDE) study, paving the way for US Food and Drug Administration (FDA) approval and subsequent commercialisation.
The DREAM trial achieved a statistically significant reduction in the co-primary endpoints of 12-month Apnoea-Hypopnea Index (AHI) responder rate.
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 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.”
Nyxoah went public with two successful initial public offers (IPOs), on Euronext Brussels in September 2020, and Nasdaq in July 2021.
In October this year, the medical technology firm raised $27m in gross proceeds to support the OSA therapy development.
