Nyxoah Secures FDA Clearance for Genio System to Treat Sleep Apnea

Nyxoah NYXH recently received FDA approval for its Genio system, an innovative therapy for moderate to severe Obstructive Sleep Apnea (OSA). Featuring a leadless, battery-free design powered by an upgradable wearable, Genio offers a unique bilateral nerve stimulation approach, now launching in the U.S. market.

The approval follows strong clinical trial results showing significant symptom reduction across all sleeping positions. With its distinctive design and proven effectiveness, Genio aims to expand treatment options and improve the quality of life for OSA patients.

More on NYXH’s Genio System

The Genio system represents a different approach to hypoglossal nerve stimulation for the treatment of OSA. Its bilateral stimulation design is paired with a leadless, battery-free solution that is both 1.5T and 3T MRI compatible, making it more convenient and less invasive for patients. The system is powered and controlled by a wearable component, which is fully upgradable, enabling technology updates without requiring additional surgeries or battery replacements.

The FDA approval was supported by the DREAM pivotal trial, which delivered strong safety and efficacy results. The study achieved both primary and secondary endpoints, including a 63.5% apnea-hypopnea index (AHI) responder rate and a 71.3% Oxygen Desaturation Index (ODI) responder rate, alongside a median AHI reduction of 70.8%. Notably, 82% of participants saw their AHI drop below 15. The trial also confirmed Genio’s efficacy regardless of sleeping position, with a 66.6% median AHI reduction in the supine position, where airway obstructions are typically more frequent, and a 71% reduction in non-supine positions.

These outcomes highlight Genio’s potential to address key clinical challenges in OSA treatment. Its consistent performance across sleeping positions, combined with an excellent safety profile, positions it as a strong alternative to existing therapies. By removing the need for implanted batteries and enabling non-invasive upgrades, Nyxoah has created a solution designed for both patient comfort and long-term adaptability, further reinforcing its competitive advantage in the OSA treatment landscape.

Industry Prospects Favoring NYXH

Per a report by Grand View Research, the global sleep apnea devices market size was estimated at $4.5 billion in 2023 and is projected to reach $6.9 billion by 2030, registering a CAGR of 6.2% from 2024 to 2030.

Key growth drivers include factors such as a growing geriatric population, a significant patient pool with sleep apnea, an increased prevalence of comorbidities linked to sleep apnea, and the development of advanced devices.

Latest Updates From NYXH’S Peers

NYXH competes with several innovative players developing advanced therapies for sleep-related breathing disorders. Here’s a look at the latest developments from some of NYXH’s key peers:

In August 2025, Inspire Medical Systems INSP commenced the full U.S. launch of its Inspire V neurostimulation system, the company’s most advanced therapy yet for obstructive sleep apnea. Building on INSP’s leadership in hypoglossal nerve stimulation, Inspire V introduces multiple upgrades, including an approximate 20% reduction in implant time, Bluetooth-enabled connectivity for patients and clinicians via the SleepSync platform, and remote software update capabilities to add future therapy features without surgery. The system also supports multiple electrode stimulation and sensing modes, enhancing personalization and treatment efficacy. With these advancements, INSP aims to expand adoption, streamline workflows for providers, and further strengthen its competitive edge in the sleep apnea treatment market.

In January 2025, ResMed RMD introduced its AirSense 11 CPAP device in India, featuring advanced capabilities such as a Personal Therapy Assistant and Care Check-In, remote software update support, and seamless integration with ResMed’s myAir and AirView platforms to boost patient adherence and remote clinician access. Complementing this, ResMed continued its innovation trajectory with the AirTouch N30i, the company’s first fabric-wrapped CPAP mask designed specifically for enhanced comfort and natural feel, featuring a Co mfiSoft fabric seal and tailored fit options, and receiving overwhelmingly positive feedback for comfort and usability.

In May 2025, LivaNova LIVN announced compelling 12-month top-line data from its OSPREY randomized controlled trial evaluating the investigational aura6000 proximal hypoglossal nerve stimulator for moderate to severe obstructive sleep apnea. The update revealed a 65% responder rate, defined as at least a 50% reduction in baseline AHI and achieving an AHI below 20, demonstrating sustained efficacy at the year mark. It also reported a remarkable 68% median reduction in both AHI (from 34.3 to 11.0) and ODI (from 34.9 to 11.1) over 12 months, reinforcing the durability of the proximal hypoglossal nerve stimulation therapy. Supporting the progress, LivaNova has already submitted a premarket approval package to the U.S. FDA, including these interim 12-month results, signaling readiness to advance toward potential commercialization.

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