Summary: Nyxoah SA has launched its Genio neurostimulator for the treatment of obstructive sleep apnea (OSA) in England. The battery-free hypoglossal neuromodulation system, which is inserted through an incision and controlled by a wearable, is now available under the NHS Specialised Services Devices Programme. The first successful implants were performed at University College London Hospitals. Nyxoah is also pursuing FDA approval in the United States following positive results from the DREAM IDE pivotal study.
Key Takeaways:
- First Implants in England: The first successful patient implants of the Genio neurostimulator were performed at University College London Hospitals, marking its commercial launch in England.
- NHS Coverage: Genio is covered under the NHS Specialised Services Devices Programme, ensuring access to the therapy through specialized centers of excellence.
- Future Expansion: Nyxoah is pursuing FDA approval in the United States.
Nyxoah SA announced the commercial launch of its Genio neuromodulation system for the treatment of obstructive sleep apnea in England, marked by the first successful implants performed at University College London Hospitals.
Genio is now covered under the NHS Specialised Services Devices Programme, enabling access to therapies through specialized centers of excellence.
The first two patients were implanted by Ryan Chin Taw Cheong, MBBS, consultant ENT and sleep surgeon at University College London Hospitals. “We are proud to be the first hospital in the UK to offer Genio to our OSA patients,” says Cheong in a release. “Genio is a groundbreaking, clinically proven therapy that addresses the unmet needs of individuals suffering from obstructive sleep apnea.”
Genio, a battery-free hypoglossal neuromodulation device, is inserted through a single incision under the chin and controlled by a wearable.
Expanding Genio’s Reach
Following the successful completion of the BLAST OSA study, the Genio system received its European CE Mark in 2019. Following the positive outcomes of the BETTER SLEEP study, Nyxoah received CE mark approval for the expansion of its therapeutic indications to Complete Concentric Collapse patients.
“Today represents an important milestone for Nyxoah as we introduce our Genio neurostimulation solution to treat obstructive sleep apnea in England,” says Olivier Taelman, CEO of Nyxoah, in a release. “Congratulations to Cheong and his team on this remarkable achievement. We look forward to expanding our collaboration with [University College London Hospitals] and other leading hospitals in England as we continue our mission to make sleep simple for OSA patients.”
Nyxoah aiming for US Food and Drug Administration approval, having announced positive outcomes from the DREAM IDE pivotal study. Genio is currently an investigational device in the United States.
Photo caption: Genio
File photo/Nyxoah
