Nyxoah Announces Preliminary Results for the Second Quarter of 2025
Nyxoah (NASDAQ: NYXH), a medical technology company focused on Obstructive Sleep Apnea (OSA) treatment, has announced preliminary Q2 2025 results. The company achieved revenue of 鈧�1.3 million, marking a 73% year-over-year increase. Operating expenses rose 50% to 鈧�20.7 million.
Key developments include FDA approval of the Genio庐 system for moderate to severe OSA patients with AHI between 15 and 65. The company maintains 鈧�43.0 million in cash and equivalents, with access to an additional 鈧�27.5 million in debt facility. Nyxoah plans to conclude ACCCESS trial enrollment early while maintaining the study's co-primary endpoints. The company faces a patent infringement lawsuit from Inspire Medical Systems and is reorganizing its R&D operations from Israel to the U.S. and Belgium.
Nyxoah (NASDAQ: NYXH), societ脿 di tecnologie medicali specializzata nel trattamento dell'apnea ostruttiva del sonno (OSA), ha reso noti i risultati preliminari del secondo trimestre 2025. L'azienda ha registrato ricavi per 鈧�1,3 milioni, in aumento del 73% su base annua. Le spese operative sono salite del 50% a 鈧�20,7 milioni.
Sviluppi chiave: approvazione FDA del sistema Genio庐 per pazienti con OSA da moderata a grave e AHI compreso tra 15 e 65. La societ脿 dispone di 鈧�43,0 milioni in liquidit脿 e equivalenti e ha accesso a una linea di debito aggiuntiva di 鈧�27,5 milioni. Nyxoah intende concludere anticipatamente l'arruolamento dello studio ACCCESS mantenendo i co-endpoint primari. L'azienda 猫 coinvolta in una causa per violazione di brevetto promossa da Inspire Medical Systems e sta riorganizzando le attivit脿 di R&S trasferendole da Israele verso Stati Uniti e Belgio.
Nyxoah (NASDAQ: NYXH), compa帽铆a de tecnolog铆a m茅dica centrada en el tratamiento de la apnea obstructiva del sue帽o (OSA), ha anunciado resultados preliminares del 2T 2025. La empresa alcanz贸 ingresos de 鈧�1,3 millones, un aumento interanual del 73%. Los gastos operativos subieron un 50% hasta 鈧�20,7 millones.
Entre los hitos destaca la aprobaci贸n por la FDA del sistema Genio庐 para pacientes con OSA moderada a grave y un AHI entre 15 y 65. La compa帽铆a cuenta con 鈧�43,0 millones en efectivo y equivalentes, y acceso a una facilidad de deuda adicional de 鈧�27,5 millones. Nyxoah planea cerrar antes de tiempo el reclutamiento del ensayo ACCCESS manteniendo los co-endpoints primarios. Enfrenta una demanda por infracci贸n de patente presentada por Inspire Medical Systems y est谩 reestructurando su I+D desde Israel hacia EE.鈥疷U. y B茅lgica.
Nyxoah (NASDAQ: NYXH)電� 韽愳噭靹� 靾橂┐氍错樃頋§(OSA) 旃橂鞐� 欤茧牓頃橂姅 鞚橂旮办垹 須岇偓搿�, 2025雲� 2攵勱赴 鞓堧箘 鞁れ爜鞚� 氚滍憸頄堨姷雼堧嫟. 須岇偓電� 毵れ稖 鈧�1.3氚彪鞚� 旮半頃� 鞝勲厔 霃欔赴 雽�牍� 73% 歃濌皜頄堨姷雼堧嫟. 鞓侅梾牍勳毄鞚� 50% 歃濌皜頃� 鈧�20.7氚彪鞓赌鞀惦媹雼�.
欤检殧 雮挫毄鞙茧電� AHI臧� 15鞐愳劀 65 靷澊鞚� 欷戨摫霃剘欷戩 OSA 頇橃瀽 雽�靸侅潣 Genio庐 鞁滌姢韰滌棎 雽�頃� FDA 鞀轨澑鞚� 韽暔霅╇媹雼�. 須岇偓電� 順勱笀 氚� 順勱笀靹膘瀽靷� 鈧�43.0氚彪鞚� 氤挫湢頃橁碃 鞛堨溂氅� 於旉皜搿� 鈧�27.5氚彪鞚� 攵�毂� 鞁滌劋鞚� 鞚挫毄頃� 靾� 鞛堨姷雼堧嫟. Nyxoah電� ACCCESS 鞛勳儊鞁滍棙鞚� 霌彪鞚� 臁瓣赴鞐� 毵堧毽暊 瓿勴殟鞚挫毵� 鞐瓣惮鞚� 瓿惦彊 1彀� 鞐旊摐韽澑韸鸽姅 鞙犾頃� 鞓堨爼鞛呺媹雼�. 霕愴暅 Inspire Medical Systems臧� 鞝滉赴頃� 韸鬼棃 旃暣 靻岇啞鞐� 歆侂┐頃� 鞛堨溂氅� 鞐瓣惮臧滊皽(R&D)鞚� 鞚挫姢霛检棙鞐愳劀 氙戈淡瓿� 氩赴鞐愲 鞛幐頃橁碃 鞛堨姷雼堧嫟.
Nyxoah (NASDAQ: NYXH), soci茅t茅 de technologies m茅dicales sp茅cialis茅e dans le traitement de l'apn茅e obstructive du sommeil (AOS), a annonc茅 des r茅sultats pr茅liminaires pour le deuxi猫me trimestre 2025. La soci茅t茅 a r茅alis茅 un chiffre d'affaires de 鈧�1,3 million, soit une hausse de 73% d'une ann茅e sur l'autre. Les charges d'exploitation ont augment茅 de 50% pour atteindre 鈧�20,7 millions.
Parmi les faits marquants figure la validation par la FDA du syst猫me Genio庐 pour les patients atteints d'AOS mod茅r茅e 脿 s茅v猫re avec un AHI compris entre 15 et 65. La soci茅t茅 dispose de 鈧�43,0 millions de tr茅sorerie et 茅quivalents et d'un acc猫s 脿 une facilit茅 de dette suppl茅mentaire de 鈧�27,5 millions. Nyxoah pr茅voit de clore anticipativement le recrutement de l'essai ACCCESS tout en pr茅servant les co-endpoints primaires de l'茅tude. L'entreprise fait face 脿 un proc猫s pour contrefa莽on de brevet intent茅 par Inspire Medical Systems et r茅organise ses activit茅s de R&D d'Isra毛l vers les 脡tats-Unis et la Belgique.
Nyxoah (NASDAQ: NYXH), ein Medizintechnikunternehmen mit Fokus auf die Behandlung der obstruktiven Schlafapnoe (OSA), hat vorl盲ufige Zahlen f眉r das 2. Quartal 2025 ver枚ffentlicht. Das Unternehmen erzielte Einnahmen von 鈧�1,3 Mio., ein Anstieg von 73% gegen眉ber dem Vorjahr. Die Betriebskosten stiegen um 50% auf 鈧�20,7 Mio..
Wesentliche Entwicklungen umfassen die FDA-Zulassung des Genio庐-Systems f眉r Patienten mit moderater bis schwerer OSA und einem AHI zwischen 15 und 65. Das Unternehmen verf眉gt 眉ber 鈧�43,0 Mio. an liquiden Mitteln und 脛quivalenten und hat Zugriff auf eine zus盲tzliche Kreditfazilit盲t von 鈧�27,5 Mio. Nyxoah plant, die Rekrutierung der ACCCESS-Studie vorzeitig abzuschlie脽en, wobei die gemeinsamen prim盲ren Endpunkte beibehalten werden. Das Unternehmen sieht sich einer Patentverletzungsklage von Inspire Medical Systems gegen眉ber und reorganisiert seine F&E-Aktivit盲ten von Israel in die USA und nach Belgien.
- FDA approval received for Genio庐 system for moderate to severe OSA patients
- Revenue increased 73% year-over-year to 鈧�1.3 million
- Access to 鈧�27.5 million additional debt facility available
- Strong cash position of 鈧�43.0 million as of June 30, 2025
- Operating expenses increased 50% to 鈧�20.7 million
- Early termination of ACCCESS trial enrollment before reaching 106 patients
- Patent infringement lawsuit filed by Inspire Medical Systems
- R&D reorganization and relocation from Israel to U.S. and Belgium
Insights
Nyxoah secures FDA approval for Genio but faces legal challenges amid 73% revenue growth and concerning cash burn rate.
Nyxoah's Q2 2025 announcement represents a pivotal moment for the company with the recent FDA approval of their Genio system for moderate to severe Obstructive Sleep Apnea (OSA). This regulatory milestone opens access to the lucrative U.S. market, potentially transforming Nyxoah's commercial trajectory after demonstrating success in Germany.
Revenue reached
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The decision to close ACCCESS trial enrollment early raises questions about statistical power, though management expresses confidence in generating meaningful data for Complete Concentric Collapse (CCC) patients鈥攁 significant untapped market without current FDA-approved treatments.
The R&D reorganization away from Israel to the U.S. and Belgium suggests strategic realignment toward commercialization priorities but may impact innovation pipeline timing.
Most concerning is the patent infringement lawsuit from Inspire Medical Systems, the established leader in hypoglossal nerve stimulation for OSA. Such litigation typically consumes significant financial and management resources, potentially impeding commercial momentum at this critical launch juncture. The litigation outcome could materially impact Nyxoah's U.S. market access and long-term competitive positioning.
Nyxoah Announces Preliminary Results for the Second Quarter of 2025
Mont-Saint-Guibert, Belgium 鈥� August 11, 2025, 7:00am CET / 1:00am ET 鈥� Nyxoah SA (Euronext Brussels/Nasdaq: NYXH)聽(鈥淣yxoah鈥� or the 鈥淐ompany鈥�), a medical technology company that develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA), today announced certain preliminary, unaudited financial results for the second quarter of 2025 and other business updates.
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Preliminary, Unaudited Second Quarter 2025 Financial Results and Business Updates
- Announced on August 8, 2025, that the U.S. Food and Drug Administration (FDA) has approved the Genio庐 system for a subset of adult 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.
- Revenue for the second quarter of 2025 is anticipated to be approximately
鈧�1.3 million , a73% increase over the second quarter of 2024. - Operating expenses for the second quarter of 2025 are anticipated to be approximately
鈧�20.7 million , a50% increase over the second quarter of 2024. - Cash, cash equivalents and financial assets are anticipated to be approximately
鈧�43.0 million at June 30, 2025. The Company also has a term debt facility with鈧�27.5 million of remaining availability which can be drawn down in two equal tranches subject to revenue and other financial milestones. - The Company expects to close patient enrollment in its ACCCESS clinical trial prior to enrolling all 106 potential patients. The study will continue, with the patients currently enrolled, with the co-primary endpoints, Apnea-Hypopnea Index (AHI) and Oxygen Desaturation Index (ODI) responder rates, assessed at 12 months post implant and followed for five years.
- The Company reorganized its global R&D function and expects to transition all ongoing R&D activities from Israel to the U.S. and Belgium.
- The Company received notice that Inspire Medical Systems, Inc. (鈥淚nspire鈥�) filed a lawsuit against the Company in the United States alleging infringement of certain patents owned by Inspire. The Company is well prepared, has the means and intends to vigorously defend itself in this matter. 聽
鈥淲e are pleased with the growth we saw in the second quarter, which provides further evidence that our commercial proof of concept in Germany has been successful,鈥� commented Olivier Taelman, Chief Executive Officer. 鈥淲ith FDA approval in hand, we expect to take the lessons learned from Germany and apply them to the U.S. as we bring our unique Genio system to the U.S. In addition, we believe that the patient population currently enrolled in the ACCCESS study will provide statistically significant results, which along with the outcomes from prior clinical evidence, will provide meaningful data with respect to the safety and efficacy of using Genio therapy in the patient population suffering from Complete Concentric Collapse (鈥淐CC鈥�). Patients with CCC represent a significant unmet need in the treatment of OSA as no FDA approved treatment currently exists.鈥�
The preliminary, unaudited financial results described in this press release, including preliminary revenue and operating expenses for the second quarter of 2025 and preliminary cash, cash equivalents and financial assets as of June 30, 2025, are estimates only. These financial results could change as a result of further review. Accordingly, you should not place undue reliance on this information. Complete financial results for the second quarter of 2025 will be announced and issued on Monday, August 18, 2025 after NASDAQ market close. A webcast of the call will be accessible via the Investor Relations page of the Nyxoah website or through this link: .
About Nyxoah
Nyxoah is a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (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 receipt of approval from the U.S. Food and Drug Administration (FDA) 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.
For more information, please visit
Caution 鈥� CE marked since 2019. FDA approved in August 2025 as prescription-only device.
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 Company鈥檚 financial results for the second quarter ended June 30, 2025; the Company鈥檚 estimates of revenue and operating expenses for the second quarter of 2025 and cash, cash equivalents and financial assets as of June 30, 2025; the Genio system; planned and ongoing clinical studies of the Genio system, including the ACCCESS study; 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; the Company鈥檚 plans to transition its ongoing R&D activities to the U.S. and Belgium; 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. 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.
Contacts: Nyxoah
John Landry, CFO
For Media
In United States
FINN Partners 鈥� Alyssa Paldo
In International/Germany
MC Services 鈥� Anne Hennecke
In Belgium/France
Backstage Communication 鈥� Gunther De Backer
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FAQ
What was Nyxoah's (NYXH) revenue growth in Q2 2025?
What FDA approval did Nyxoah receive for its Genio system in 2025?
How much cash and equivalents does Nyxoah (NYXH) have as of Q2 2025?
What legal challenges is Nyxoah facing in 2025?
What changes is Nyxoah making to its ACCCESS clinical trial in 2025?
