FDA Grants Approval of Hypoglossal Nerve Stimulation System for Obstructive Sleep Apnea Treatment

Colin Huntley, MD

(Credit: Jefferson Health)

According to a recent announcement, the FDA has approved Nyxoah’s Genio hypoglossal nerve stimulation system for patients with moderate to severe obstructive sleep apnea (OSA) who have an apnea-hypopnea index (AHI) of greater than or equal to 15 and less than or equal to 65.¹

Genio is designed to deliver bilateral stimulation through a leadless system and features a nonimplanted battery solution that is compatible with full-body 1.5T and 3T MRI. Nyxoah noted that the system is powered and controlled by a wearable component, which is fully upgradable, allowing patients with OSA to access the latest technology without needing additional surgeries for updates or battery replacements.

The approval was supported by positive data from the multicenter, prospective, open-label, interventional DREAM trial (NCT03868618) which assessed the efficacy and safety of the Genio system among 115 patients with OSA for 12 months. Overall, the study met both its primary and secondary end points, showing an AHI responder rate of 63.5% (n = 73, P = .002) and an Oxygen Desaturation Index (ODI) responder rate of 71.3% (n = 82, P <.001) at 12 months. Notably, findings from the trial revealed that 82.0% of all participants from DREAM had their AHI scores drop below 15 or lower.^2,3

"The Genio system's approval represents a major addition to the treatment options available to physicians treating patients with OSA,” Colin Huntley, MD, associate professor in the Department of Otolaryngology Head & Neck Surgery at Thomas Jefferson University, said in a statement.¹ “This unique bilateral stimulation technology has demonstrated consistent efficacy across all sleeping positions, including the challenging supine position, while maintaining an excellent safety profile.”

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Participants entered the DREAM study with a mean AHI of 28.0, mean ODI of 27.0 and mean body mass index of 28.5. At 12 months, patients with OSA demonstrated a median AHI reduction of 70.8%, with similar AHI improvements observed in supine and nonsupine sleeping positions. In a supine position, the findings showed a 66.6% median AHI reduction, even though the number of airway obstructions can double in this position, and a 71.0% reduction in AHI in a nonsupine position among patients with OSA.

The company noted that based on these findings, Genio was demonstrated strong efficacy regardless of a patient's sleeping position and that it is the only therapy with such clinical evidence in a large, multicenter, prospective study that used data from a full night polysomnography. In terms of safety, the investigational treatment was favorable, with 11 serious adverse events (SAEs), in 10 patients with OSA resulting in an SAE rate of 8.7%. Among the 11 reported SAEs, the company noted that 3 were device related and there were 3 explants.

"Today marks a defining moment for Nyxoah and for U.S. patients suffering from OSA. With the FDA’s marketing approval of the Genio system, we are proud to bring this innovative therapy to the U.S. market,” Olivier Taelman, chief executive officer at Nyxoah, said in a statement.¹ “Our mission has always been to make sleep simple for OSA patients by offering them a solution that empowers better sleep. We look forward to the successful execution of our U.S. commercialization strategy.”

REFERENCES
1. Nyxoah Receives Approval from FDA for Genio® System for the Treatment of Obstructive Sleep Apnea. News Release. Nyxoah. Published August 8, 2025. Accessed August 20, 2025. https://www.globenewswire.com/news-release/2025/08/08/3130374/0/en/Nyxoah-Receives-Approval-from-FDA-for-Genio-System-for-the-Treatment-of-Obstructive-Sleep-Apnea.html
2. Nyxoah Announces DREAM U.S. Pivotal Study Meets Primary Endpoints. News Release. Nyxoah. Published March 19, 2024. Accessed August 20, 2025. https://www.globenewswire.com/news-release/2024/03/19/2848963/0/en/Nyxoah-Announces-DREAM-U-S-Pivotal-Study-Meets-Primary-Endpoints.html
3. Woodson BT, Suurna MV, Gillespie MB, et al. Multicentre study conducted across centres in the USA, Europe and Australia to assess the safety and effectiveness of a bilateral hypoglossal nerve stimulation system for the treatment of obstructive sleep apnoea in adults: a protocol for a pivotal, multicentre, open-label, single-arm study. BMJ Open. 2024;14(12):e085218. Published 2024 Dec 20. doi:10.1136/bmjopen-2024-085218