Nyxoah SA announced the commercial launch of its Genio hypoglossal neurostimulation system in the Middle East on February 19, 2025, marking a significant milestone as the first neurostimulation therapy for obstructive sleep apnea (OSA) available in the region. The launch was commemorated by the successful implantation of the first patient at Saudi German Hospital in Dubai, United Arab Emirates.
First Regional Implementation
Dr. Ahmed Yassin Bahgat, Consultant Otolaryngologist at Saudi German Hospital, performed the inaugural Genio implant procedure. "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," Dr. Bahgat stated. "Genio is an innovative, clinically proven, and smart therapy designed to effectively treat individuals with Obstructive Sleep Apnea who are unable to tolerate CPAP."
The procedure establishes Saudi German Hospital as the pioneering facility in the region to offer this alternative treatment option for OSA patients who struggle with continuous positive airway pressure (CPAP) therapy compliance.
Technology and Clinical Evidence
The Genio system represents a novel approach to OSA treatment through hypoglossal nerve stimulation. The device is battery-free and requires only a single incision under the chin for implantation, with patient control managed through a wearable device. This minimally invasive approach differentiates it from other neurostimulation therapies in the sleep medicine field.
Nyxoah's clinical development program has demonstrated the system's efficacy across multiple studies. The BLAST OSA study led to European CE Mark approval in 2019, while the BETTER SLEEP study resulted in expanded therapeutic indications to include Complete Concentric Collapse (CCC) patients—a population currently contraindicated for competing therapies. The company has also reported positive outcomes from the DREAM IDE pivotal study, which supports FDA approval and U.S. commercialization efforts.
Market Expansion Strategy
Olivier Taelman, CEO of Nyxoah, emphasized the strategic significance of the Middle East launch. "The commercial launch of Genio in the UAE marks an historic milestone as the first-ever neurostimulation therapy for Obstructive Sleep Apnea in the region," Taelman said. "We are proud to bring this groundbreaking, patient-centric solution to the Middle East, offering new hope to patients who cannot tolerate CPAP."
The expansion into the Middle East represents part of Nyxoah's broader global commercialization strategy. The company has established a presence in European markets since receiving CE Mark approval and is pursuing regulatory approval in the United States through its ongoing FDA submission process.
Addressing Unmet Medical Need
Obstructive sleep apnea affects approximately one billion people globally, with CPAP therapy remaining the gold standard treatment. However, CPAP intolerance represents a significant clinical challenge, with studies indicating that 30-50% of patients struggle with long-term compliance due to mask discomfort, claustrophobia, and other factors.
The Genio system specifically targets this patient population by providing an implantable alternative that eliminates the need for nightly mask wear. The therapy works by delivering controlled electrical stimulation to the hypoglossal nerve, which controls tongue movement and helps maintain airway patency during sleep.
Regulatory Status and Future Outlook
While Genio has received CE Mark approval for European commercialization, the device remains investigational in the United States and is limited to investigational use under federal law. Nyxoah continues to work toward FDA approval based on data from its DREAM IDE pivotal study.
The company went public through dual listings on Euronext Brussels in September 2020 and NASDAQ in July 2021, providing capital to support its global expansion and regulatory efforts. The Middle East launch represents a key milestone in Nyxoah's international commercialization strategy as it seeks to establish Genio as a leading alternative therapy for OSA patients worldwide.
