Nyxoah's innovative Genio system for treating obstructive sleep apnea (OSA) continues its global expansion with successful commercial launches in both the Middle East and England, offering new hope to patients who cannot tolerate conventional CPAP therapy.
First Genio Implant in Middle East Performed in Dubai
In a significant milestone for sleep medicine in the region, the first Genio implant in the Middle East was successfully performed at Saudi German Hospital in Dubai, United Arab Emirates. Dr. Ahmed Yassin Bahgat, Consultant Otolaryngologist at the hospital, conducted the procedure with support from Odin Healthcare, Nyxoah's regional partner.
"We are honored to be the first hospital in the UAE, as well as the Middle East and Africa, to offer Genio to our OSA patients," said Dr. Bahgat. "Genio is an innovative, clinically proven, and smart therapy designed to effectively treat individuals with Obstructive Sleep Apnea who are unable to tolerate CPAP."
This launch represents the first-ever neurostimulation therapy for OSA available in the Middle East, addressing a significant unmet need in a region where sleep disorders affect millions.
England Welcomes Genio with First Implants at UCLH
Simultaneously, Nyxoah has expanded its European presence with the commercial launch of Genio in England. The first two patients received their implants at University College London Hospitals (UCLH), performed by Mr. Ryan Chin Taw Cheong, Consultant ENT and Sleep Surgeon.
The Genio system is now covered under the NHS Specialised Services Devices Programme (SSDP), ensuring access to this innovative therapy through specialized centers of excellence across England.
"We are proud to be the first hospital in the UK to offer Genio to our OSA patients," Mr. Cheong remarked. "Genio is a groundbreaking, clinically proven therapy that addresses the unmet needs of individuals suffering from Obstructive Sleep Apnea."
The Genio System: A Revolutionary Approach to OSA Treatment
Obstructive sleep apnea affects approximately one billion people worldwide and is characterized by repeated breathing interruptions during sleep. While continuous positive airway pressure (CPAP) remains the standard treatment, many patients struggle with compliance due to discomfort and inconvenience.
The Genio system offers a fundamentally different approach through hypoglossal nerve stimulation. Unlike other neurostimulation devices, Genio is battery-free and requires only a single incision under the chin for implantation. The system is controlled by a wearable device, offering patients greater comfort and convenience.
Olivier Taelman, CEO of Nyxoah, emphasized the significance of these global expansions: "With strong clinical evidence and growing global adoption, we remain committed to expanding access to Genio and transforming the treatment of OSA worldwide."
Clinical Evidence and Regulatory Status
The Genio system received its European CE Mark in 2019 following the successful completion of the BLAST OSA study. Subsequent clinical research, including the BETTER SLEEP study, led to expanded CE mark approval for patients with Complete Concentric Collapse (CCC), a condition that is contraindicated in competing therapies.
In the United States, Nyxoah has reported positive outcomes from the DREAM IDE pivotal study, which will support the company's application for FDA approval. Currently, the Genio system remains an investigational device in the U.S. market.
Future Outlook
As Nyxoah continues its global expansion, the company aims to make the Genio system accessible to more patients suffering from OSA who cannot use or tolerate CPAP therapy. The successful launches in the Middle East and England demonstrate growing clinical acceptance of this innovative approach to neuromodulation therapy.
With approximately one billion people affected by OSA worldwide and many unable to adhere to conventional treatments, the market potential for alternative therapies like Genio remains substantial. Nyxoah's continued clinical research and geographic expansion position the company to address this significant unmet medical need across diverse healthcare systems globally.
