Nyxoah Receives Approval from FDA for Genio庐 System for the Treatment of Obstructive Sleep Apnea
Nyxoah (NASDAQ: NYXH) has received FDA approval for its Genio庐 system, a breakthrough treatment for moderate to severe Obstructive Sleep Apnea (OSA). The approval covers patients with an Apnea-Hypopnea Index (AHI) between 15 and 65.
The Genio system represents a novel approach to hypoglossal nerve stimulation, featuring bilateral stimulation and a unique leadless design that is MRI compatible. The system's efficacy was demonstrated in the DREAM pivotal trial, achieving a 63.5% AHI responder rate and an impressive 70.8% median AHI reduction.
Notably, the system showed consistent effectiveness across all sleeping positions, with a 66.6% median AHI reduction in supine position and 71.0% reduction in non-supine position. The company has officially launched its U.S. commercialization efforts.
Nyxoah (NASDAQ: NYXH) ha ottenuto l'approvazione della FDA per il suo sistema Genio庐, una terapia innovativa per l'Apnea Ostruttiva del Sonno (OSA) da moderata a grave. L'autorizzazione riguarda pazienti con un Indice Apnea-Ipopnea (AHI) compreso tra 15 e 65.
Il sistema Genio propone un approccio nuovo alla stimolazione del nervo ipoglosso, con stimolazione bilaterale e un design unico senza elettrodi (leadless) e compatibile con la risonanza magnetica (MRI). L'efficacia 猫 stata dimostrata nello studio pivotale DREAM, che ha registrato un tasso di responder AHI del 63,5% e una riduzione mediana dell'AHI del 70,8%.
In particolare, il sistema ha mantenuto efficacia in tutte le posizioni di sonno, con una riduzione mediana dell'AHI del 66,6% in posizione supina e del 71,0% in posizione non supina. L'azienda ha avviato ufficialmente la commercializzazione negli Stati Uniti.
Nyxoah (NASDAQ: NYXH) ha recibido la aprobaci贸n de la FDA para su sistema Genio庐, un tratamiento innovador para la Apnea Obstructiva del Sue帽o (OSA) de moderada a grave. La aprobaci贸n se aplica a pacientes con un 脥ndice de Apnea-Hipopnea (AHI) entre 15 y 65.
El sistema Genio representa un nuevo enfoque de la estimulaci贸n del nervio hipogloso, con estimulaci贸n bilateral y un dise帽o 煤nico sin electrodos (leadless) y compatible con resonancia magn茅tica (MRI). Su eficacia se demostr贸 en el ensayo pivotal DREAM, alcanzando una tasa de respondedores AHI del 63,5% y una reducci贸n mediana del AHI del 70,8%.
De forma notable, el sistema mostr贸 eficacia constante en todas las posiciones al dormir, con una reducci贸n mediana del AHI del 66,6% en dec煤bito supino y del 71,0% en posiciones no supinas. La compa帽铆a ha iniciado oficialmente la comercializaci贸n en EE.聽UU.
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Genio 鞁滌姢韰滌潃 順�氚戩嫚瓴�(靹り敞頃橃嫚瓴�) 鞛愱饭鞐� 雽�頃� 靸堧鞖� 鞝戧芳鞙茧, 鞏戩浮 鞛愱饭瓿� 毽摐毽姢(leadless) 靹り硠 氚� MRI 順疙櫂靹�鞚� 韸轨鞙茧 頃╇媹雼�. DREAM 頂茧炒韮�(欤检殧) 鞛勳儊鞐愳劀 鞙犿毃靹膘澊 鞛呾霅橃柎 AHI 氚橃潙毳� 63.5%鞕赌 AHI 欷戩暀臧� 70.8% 臧愳唽毳� 雼劚頄堨姷雼堧嫟.
韸鬼瀳 氇摖 靾橂┐ 鞛愳劯鞐愳劀 鞚缄磤霅� 須臣毳� 氤挫榾鞙茧┌, 鞎欖櫠撵渼(霌膘潉 雽�瓿� 雸勳毚 鞛愳劯)鞐愳劀 AHI 欷戩暀臧� 66.6% 臧愳唽, 牍�-鞎欖櫠撵渼 鞛愳劯鞐愳劀 71.0% 臧愳唽毳� 旮半頄堨姷雼堧嫟. 須岇偓電� 氙戈淡鞐愳劀鞚� 靸侅毄頇旊ゼ 瓿奠嫕鞝侅溂搿� 鞁滌瀾頄堨姷雼堧嫟.
Nyxoah (NASDAQ: NYXH) a obtenu l'approbation de la FDA pour son syst猫me Genio庐, un traitement innovant de l'apn茅e obstructive du sommeil (AOS) mod茅r茅e 脿 s茅v猫re. L'autorisation concerne les patients ayant un indice d'apn茅e-hypopn茅e (AHI) compris entre 15 et 65.
Le syst猫me Genio propose une nouvelle approche de la stimulation du nerf hypoglosse, avec une stimulation bilat茅rale et un design unique sans 茅lectrode (leadless) et compatible IRM (MRI). Son efficacit茅 a 茅t茅 d茅montr茅e dans l'essai pivot DREAM, avec un taux de r茅pondeurs AHI de 63,5% et une r茅duction m茅diane de l'AHI de 70,8%.
Notamment, le syst猫me a montr茅 une efficacit茅 constante dans toutes les positions de sommeil, avec une r茅duction m茅diane de l'AHI de 66,6% en d茅cubitus dorsal et de 71,0% en positions non dorsales. La soci茅t茅 a officiellement lanc茅 la commercialisation aux 脡tats-Unis.
Nyxoah (NASDAQ: NYXH) hat die Zulassung der FDA f眉r sein 骋别苍颈辞庐-厂测蝉迟别尘 erhalten, eine neuartige Behandlung der moderaten bis schweren obstruktiven Schlafapnoe (OSA). Die Zulassung gilt f眉r Patienten mit einem Apnoe-Hypopnoe-Index (AHI) zwischen 15 und 65.
Das Genio-System verfolgt einen neuen Ansatz zur Stimulation des Hypoglossusnervs, mit bilateraler Stimulation und einem einzigartigen leadless-Design (ohne Leads), das MRI-kompatibel ist. Die Wirksamkeit wurde in der pivotalen DREAM-Studie gezeigt, mit einer AHI-Responder-Rate von 63,5% und einer beeindruckenden medianen AHI-Reduktion von 70,8%.
Bemerkenswert ist, dass das System in allen Schlafpositionen konsistent wirksam war, mit einer medianen AHI-Reduktion von 66,6% in R眉ckenlage und 71,0% in Nicht-R眉ckenlage. Das Unternehmen hat den US-Vertrieb offiziell gestartet.
- FDA approval received for Genio system for moderate to severe OSA treatment
- Strong clinical results with 70.8% median AHI reduction in DREAM trial
- 82% of DREAM study subjects achieved AHI scores below 15
- Unique bilateral stimulation technology effective in all sleeping positions
- Full-body 1.5T and 3T MRI compatibility
- No battery replacement surgeries required due to external power source
- Limited to patients with specific AHI range (15-65)
- Requires wearing external component for power and control
Insights
Nyxoah's FDA approval for Genio represents a major regulatory milestone, enabling US market entry with a differentiated OSA treatment technology.
The FDA approval of Nyxoah's Genio system marks a crucial regulatory achievement that opens the large US market for this novel OSA treatment. The approval covers a specific patient population with moderate to severe OSA having an AHI between 15 and 65, representing a significant addressable market.
What distinguishes this approval is the unique technological features of the Genio system. Unlike other hypoglossal nerve stimulation devices, Genio offers bilateral stimulation, is completely leadless, and comes with full-body MRI compatibility at both 1.5T and 3T strengths. The non-implanted battery design with a wearable component is particularly noteworthy, as it allows for technology upgrades without additional surgeries 鈥� a significant advantage over competitors requiring surgical replacement for battery or technology updates.
The DREAM pivotal trial data supporting this approval is compelling, showing a 63.5% AHI responder rate and an impressive 70.8% median AHI reduction. Most remarkably, 82.0% of subjects saw their AHI scores drop below 15, effectively moving many patients from moderate/severe categories to mild OSA or better. The position-specific efficacy data demonstrating consistent performance regardless of sleeping position (66.6% supine vs. 71.0% non-supine AHI reduction) represents a meaningful clinical differentiator for this technology.
With this approval, Nyxoah has officially launched US commercialization, transitioning from a development-stage company to a commercial entity in the world's largest medical device market. This regulatory milestone should significantly expand the company's market opportunity and revenue potential.
The Genio system's approval introduces a disruptive alternative in the hypoglossal nerve stimulation (HGNS) market for OSA. What sets this device apart from competitors is its innovative architecture 鈥� while traditional HGNS systems require implanted batteries needing surgical replacement every 7-10 years, Genio's external power supply eliminates this need entirely.
The bilateral stimulation approach represents a technical innovation compared to unilateral stimulation used by competitors. This may contribute to the strong position-independent efficacy demonstrated in the clinical data. The full MRI compatibility also provides a meaningful advantage, as many OSA patients have comorbidities requiring diagnostic imaging.
From a product lifecycle perspective, the upgradable wearable component creates a significant competitive advantage. While competing devices lock patients into a specific technology generation until surgical replacement, Genio allows iterative improvements through external component upgrades. This architecture creates a platform strategy that could allow Nyxoah to introduce enhanced algorithms and features without requiring patients to undergo additional surgeries.
The addressable market for this technology is substantial. With approval for AHI scores between 15-65, Genio targets both moderate and severe OSA patients who have failed continuous positive airway pressure (CPAP) therapy. The positive efficacy in supine sleeping positions specifically addresses a critical unmet need, as supine sleeping significantly worsens OSA for many patients.
The US market entry represents a major inflection point for Nyxoah, transitioning from primarily European operations to competing in the much larger US market against established players. The execution of their commercialization strategy, including reimbursement pathways and physician adoption, will be critical determinants of their success in capturing market share.
INSIDE INFORMATION
REGULATED INFORMATION
Nyxoah Receives Approval from FDA for Genio庐 System for the Treatment of Obstructive Sleep Apnea
U.S. Commercialization Officially Launched
Mont-Saint-Guibert, Belgium 鈥� August 8, 2025, 10:10pm CET / 4:10pm ET 鈥� Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (鈥淣yxoah鈥� or the 鈥淐ompany鈥�), a medical technology company that develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA) through neuromodulation, today announced that the U.S. Food and Drug Administration (FDA) has approved the Genio system for a subset of patients with moderate to severe OSA with an Apnea-Hypopnea Index (AHI) of greater than or equal to 15 and less than or equal to 65.
Genio is a different approach to hypoglossal nerve stimulation (HGNS) for the treatment of OSA. Genio鈥檚 unique design utilizes bilateral stimulation, and offers patients a leadless, full-body 1.5T and 3T MRI compatible, non-implanted battery solution, powered and controlled by a wearable component. The wearable component is fully upgradable, providing Genio patients with access to this technology without requiring additional surgeries for technology updates or battery replacements.
"Today marks a defining moment for Nyxoah and for U.S. patients suffering from OSA. With the FDA鈥檚 marketing approval of the Genio system, we are proud to bring this innovative therapy to the U.S. market,鈥� commented Olivier Taelman, Nyxoah鈥檚 Chief Executive Officer. 鈥淥ur 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.鈥�
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The Genio system鈥檚 FDA approval was supported by the high-quality, differentiated safety and efficacy data from the Company's DREAM pivotal trial. The DREAM study met both its primary and secondary endpoints demonstrating an AHI responder rate of
Importantly, the DREAM study demonstrated that Genio is efficacious regardless of a patient's sleeping position and, to our knowledge the only therapy with such clinical evidence in a large, multicenter, prospective clinical study using data from a full night polysomnography. This is a critical differentiator as on average, people sleep in a supine position between
"The Genio system's approval represents a major addition to the treatment options available to physicians treating patients with OSA,鈥� said Colin Huntley MD, Associate Professor, Department of Otolaryngology Head & Neck Surgery, Thomas Jefferson University. 鈥淭his unique bilateral stimulation technology has demonstrated consistent efficacy across all sleeping positions, including the challenging supine position, while maintaining an excellent safety profile.鈥�
About Nyxoah
Nyxoah is a medical technology company focused on the development and commercialization of innovative solutions to treat OSA. Nyxoah鈥檚 lead solution is the Genio system, a patient-centered, leadless and battery-free hypoglossal neurostimulation therapy for OSA, the world鈥檚 most common sleep disordered breathing condition that is associated with increased mortality risk and cardiovascular comorbidities. Nyxoah is driven by the vision that OSA patients should enjoy restful nights and feel enabled to live their life to its fullest.
Following the successful completion of the BLAST OSA study, the Genio system received its European CE Mark in 2019. Nyxoah completed two successful IPOs: on Euronext Brussels in September 2020 and NASDAQ in July 2021. Following the positive outcomes of the BETTER SLEEP study, Nyxoah received CE mark approval for the expansion of its therapeutic indications to Complete Concentric Collapse (CCC) patients, currently contraindicated in competitors鈥� therapy. Additionally, the Company announced positive outcomes from the DREAM IDE pivotal study and U.S. FDA approval of a Premarket Approval application.
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FORWARD-LOOKING STATEMENTS
Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company鈥檚 or, as appropriate, the Company directors鈥� or managements鈥� current expectations regarding the Genio system; planned and ongoing clinical studies of the Genio system; the potential advantages of the Genio system; Nyxoah鈥檚 goals with respect to the development, regulatory pathway and potential use of the Genio system; the Company's commercialization strategy and entrance to the U.S. market; and the Company's results of operations, financial condition, liquidity, performance, prospects, growth and strategies. By their nature, forward-looking statements involve a number of risks, uncertainties, assumptions and other factors that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties, assumptions and factors could adversely affect the outcome and financial effects of the plans and events described herein. Additionally, these risks and uncertainties include, but are not limited to, the risks and uncertainties set forth in the 鈥淩isk Factors鈥� section of the Company鈥檚 Annual Report on Form 20-F for the year ended December 31, 2024, filed with the Securities and Exchange Commission (鈥淪EC鈥�) on March 20, 2025, and subsequent reports that the Company files with the SEC. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities are not guarantees of future performance and should not be taken as a representation that such trends or activities will continue in the future. In addition, even if actual results or developments are consistent with the forward-looking statements contained in this press release, those results or developments may not be indicative of results or developments in future periods. No representations and warranties are made as to the accuracy or fairness of such forward-looking statements. As a result, the Company expressly disclaims any obligation or undertaking to release any updates or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based, except if specifically required to do so by law or regulation. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person's officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.
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Nyxoah
John Landry, CFO
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In United States
FINN Partners 鈥� Alyssa Paldo
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In Belgium/France
Backstage Communication 鈥� Gunther De Backer
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FAQ
What is the FDA-approved AHI range for Nyxoah's Genio system?
What were the key results from Nyxoah's DREAM trial for the Genio system?
How effective is NYXH's Genio system in different sleeping positions?
What makes Nyxoah's Genio system different from other OSA treatments?
When will Nyxoah begin commercialization of the Genio system in the US?
