Sleep Disorders

FDA Clears Genio System for Obstructive Sleep Apnea

Diana Ernst, RPh
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Publish Date
Man wearing Genio system.
Credit: Nyxoah.
Genio is a bilateral hypoglossal nerve stimulation system that consists of an implantable stimulator and a sleep wearable.
The Genio system is now available in the US for OSA patients who meet eligibility criteria.

The Food and Drug Administration (FDA) has approved the Genio® system for the treatment of patients with moderate to severe obstructive sleep apnea (OSA) with an apnea-hypopnea index (AHI) of greater than or equal to 15 and less than or equal to 65.

Genio is a bilateral hypoglossal nerve stimulation system that consists of an implant that is inserted into the chin area and a wearable device that is programmed with therapy settings and is the power source of the implantable stimulator. The battery-free stimulator helps to maintain an open airway by delivering stimulation to both hypoglossal nerve branches, resulting in the contraction of tongue muscles. The Genio smartphone app allows a user to pause or resume treatment, adjust the stimulation intensity, and track progress. 

The approval was based on data from the DREAM trial (ClinicalTrials.gov Identifier: NCT03868618), a prospective, open-label, interventional study that assessed the safety and efficacy of Genio in 115 OSA patients (mean AHI: 28.0; mean oxygen desaturation index [ODI]: 27.0; mean body mass index: 28.5). The coprimary endpoints were AHI responder rate, per the Sher criteria, and ODI responder rate, both measured at 12 months.

Findings showed the trial met both primary endpoints, demonstrating an AHI responder rate of 63.5% (P =.002) and an ODI responder rate of 71.3% (P <.001), with a median 12-month AHI reduction of 70.8%. Similar improvements were observed in supine and non-supine sleeping positions. Moreover, AHI scores below 15 were reported in 82% of study participants. Regarding safety, there were 11 serious adverse events during the trial, 3 of which were device related. 

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

According to Nyxoah, the Genio system is now available in the US for OSA patients who meet eligibility criteria.

This article originally appeared on MPR

References:
  1. Nyxoah receives approval from FDA for Genio® system for the treatment of obstructive sleep apnea. News release. Nyxoah. August 8, 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. May 19, 2024. https://nyxoah.gcs-web.com/news-releases/news-release-details/nyxoah-announces-dream-us-pivotal-study-meets-primary-endpoints.