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 PRESS RELEASE

EQS-News: Nyxoah erhält Approvable Letter für sein Genio®-System von d...

EQS-News: Nyxoah SA. / Schlagwort(e): Sonstiges Nyxoah erhält Approvable Letter für sein Genio®-System von der FDA 26.03.2025 / 09:45 CET/CEST Für den Inhalt der Mitteilung ist der Emittent / Herausgeber verantwortlich. Nyxoah erhält Approvable Letter für sein Genio®-System von der FDA Mont-Saint-Guibert, Belgien – 26. März 2025 – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) („Nyxoah” oder das „Unternehmen”), ein Medizintechnikunternehmen, das innovative Technologien zur Behandlung der obstruktiven Schlafapnoe („Obstructive Sleep Apnea“, OSA) mithilfe von Neurostimulation ...

 PRESS RELEASE

EQS-News: FDA Issues Nyxoah an Approvable Letter for its Genio® System

EQS-News: Nyxoah SA. / Key word(s): Miscellaneous FDA Issues Nyxoah an Approvable Letter for its Genio® System 26.03.2025 / 09:45 CET/CEST The issuer is solely responsible for the content of this announcement. FDA Issues Nyxoah an Approvable Letter for its Genio® System Mont-Saint-Guibert, Belgium – March 26, 2025, 8:00am CET / 3:00am ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), that develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA) through neuromodulation, today announced that the U.S. Food and Drug Administra...

 PRESS RELEASE

FDA Issues Nyxoah an Approvable Letter for its Genio® System

FDA Issues Nyxoah an Approvable Letter for its Genio® System INSIDE INFORMATIONREGULATED INFORMATION FDA Issues Nyxoah an Approvable Letter for its Genio® System Mont-Saint-Guibert, Belgium – March 26, 2025, 8:00am CET / 3:00am ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “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 issued an Approvable Letter regarding the Company's Pre-Market Approval (PMA) application for the Genio® syst...

 PRESS RELEASE

La FDA Délivre à Nyxoah une Lettre d'Approuvabilité pour son système G...

La FDA Délivre à Nyxoah une Lettre d'Approuvabilité pour son système Genio®   INFORMATIONS PRIVILÉGIÉESINFORMATIONS RÉGLEMENTÉES La FDA Délivre à Nyxoah une Lettre d'Approuvabilité pour son Système Genio® Mont-Saint-Guibert, Belgique – 26 mars 2025, 8h00 CET / 3h00 ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (« Nyxoah » ou la « Société »), une société de technologie médicale développant des alternatives thérapeutiques innovantes pour l'apnée obstructive du sommeil (AOS) par la neuromodulation, a annoncé aujourd'hui que la Food and Drug Administration (FDA) des États-Unis a émi...

Jamila El Bougrini ... (+2)
  • Jamila El Bougrini
  • Thibaut Voglimacci-Stephanopoli
 PRESS RELEASE

EQS-News: Nyxoah Reports Fourth Quarter and Financial Year 2024 Financ...

EQS-News: Nyxoah SA. / Key word(s): Annual Results Nyxoah Reports Fourth Quarter and Financial Year 2024 Financial and Operating Results 13.03.2025 / 07:00 CET/CEST The issuer is solely responsible for the content of this announcement. Nyxoah Reports Fourth Quarter and Financial Year 2024 Financial and Operating Results FDA PMA Application Review Nearing Conclusion Positioned for U.S. Commercial Launch in the First Quarter 2025 Mont-Saint-Guibert, Belgium – March 13, 2025, 7:00am CET / 2:00am ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), ...

 PRESS RELEASE

EQS-News: Nyxoah gibt Finanzergebnisse für das vierte Quartal und das ...

EQS-News: Nyxoah SA. / Schlagwort(e): Jahresergebnis Nyxoah gibt Finanzergebnisse für das vierte Quartal und das Geschäftsjahr 2024 bekannt und informiert über die Unternehmensentwicklung 13.03.2025 / 07:00 CET/CEST Für den Inhalt der Mitteilung ist der Emittent / Herausgeber verantwortlich. Nyxoah gibt Finanzergebnisse für das vierte Quartal und das Geschäftsjahr 2024 bekannt und informiert über die Unternehmensentwicklung  FDA PMA-Antragsprüfung vor dem Abschluss  Positioniert für die Markteinführung in den USA im ersten Quartal 2025 Mont-Saint-Guibert, Belgien - 13....

 PRESS RELEASE

Nyxoah Reports Fourth Quarter and Financial Year 2024 Financial and O...

Nyxoah Reports Fourth Quarter and Financial Year 2024 Financial and Operating Results REGULATED INFORMATION Nyxoah Reports Fourth Quarter and Financial Year 2024 Financial and Operating ResultsFDA PMA Application Review Nearing ConclusionPositioned for U.S. Commercial Launch in March 2025 Mont-Saint-Guibert, Belgium – March 13, 2024, 7:00am CET / 2:00am ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), that develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA) through neuromodulation, today reported financial and operating results for t...

 PRESS RELEASE

Nyxoah Publie ses Résultats Financiers et Opérationnels pour le Quatri...

Nyxoah Publie ses Résultats Financiers et Opérationnels pour le Quatrième Trimestre et l'Exercice 2024 INFORMATIONS RÉGLEMENTÉES Nyxoah Publie ses Résultats Financiers et Opérationnels pour le Quatrième Trimestre et l'Exercice 2024L'examen de la demande d'autorisation de mise sur le marché de la FDA touche à sa finPrêt pour un lancement commercial aux États-Unis au cours en mars 2025 Mont-Saint-Guibert, Belgique – 13 mars 2025, 7h00 CET / 2h00 ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (« Nyxoah » ou la « Société ») une société de technologie médicale développant des alternatives thé...

 PRESS RELEASE

Nyxoah Publiera ses Résultats Financiers du Quatrième Trimestre et de ...

Nyxoah Publiera ses Résultats Financiers du Quatrième Trimestre et de l’Exercice 2024 le 13 Mars 2025 Nyxoah Publiera ses Résultats Financiers du Quatrième Trimestre et de l’Exercice 2024 le 13 Mars 2025 Mont-Saint-Guibert, Belgique – 10 mars 2025, 22h05 CET / 17h05 ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (« Nyxoah » ou la « Société »), une société de technologie médicale développant des alternatives thérapeutiques révolutionnaires pour l'apnée obstructive du sommeil (AOS) par la neuromodulation, a annoncé aujourd'hui que la Société publiera ses résultats financiers pour le quatriè...

 PRESS RELEASE

Nyxoah to Release Fourth Quarter and Financial Year 2024 Financial Res...

Nyxoah to Release Fourth Quarter and Financial Year 2024 Financial Results on March 13, 2025 Nyxoah to Release Fourth Quarter and Financial Year 2024 Financial Results on March 13, 2025 Mont-Saint-Guibert, Belgium – Monday, March 10, 2025, 10:05pm CET / 5:05pm ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), that develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA) through neuromodulation, today announced that the Company will release financial results for the fourth quarter and financial year 2024 on Thursday, March 13, 2025. Company m...

 PRESS RELEASE

Nyxoah to Participate in the Oppenheimer 35th Annual Healthcare MedTec...

Nyxoah to Participate in the Oppenheimer 35th Annual Healthcare MedTech & Services Conference Nyxoah to Participate in the Oppenheimer 35th Annual Healthcare MedTech & Services Conference Mont-Saint-Guibert, Belgium – March 3, 2025, 10:30pm CET / 4:30pm ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), that develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA) through neuromodulation, today announced that the Company will participate in the Oppenheimer 35th Annual Healthcare MedTech & Services Conference, which takes place March 17 – 20, ...

 PRESS RELEASE

EQS-News: Nyxoah gibt die Markteinführung der innovativen Genio®-Thera...

EQS-News: Nyxoah SA. / Schlagwort(e): Markteinführung Nyxoah gibt die Markteinführung der innovativen Genio®-Therapie im Nahen Osten bekannt 19.02.2025 / 07:05 CET/CEST Für den Inhalt der Mitteilung ist der Emittent / Herausgeber verantwortlich. Nyxoah gibt die Markteinführung der innovativen Genio®-Therapie im Nahen Osten bekannt Der erste Patient hat im Saudi German Hospital in Dubai, Vereinigte Arabische Emirate, ein Genio-Implantat erhalten Mont-Saint-Guibert, Belgien – 19. Februar 2025, 07:05 Uhr MEZ – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) („Nyxoah” oder das ...

 PRESS RELEASE

EQS-News: Nyxoah Announces Commercial Launch of Genio® Breakthrough Th...

EQS-News: Nyxoah SA. / Key word(s): Market Launch Nyxoah Announces Commercial Launch of Genio® Breakthrough Therapy in the Middle East 19.02.2025 / 07:05 CET/CEST The issuer is solely responsible for the content of this announcement. Nyxoah Announces Commercial Launch of Genio® Breakthrough Therapy in the Middle East First patient implanted with Genio at Saudi German Hospital in Dubai, United Arab Emirates Mont-Saint-Guibert, Belgium – February 19, 2025, 7:05am CET / 1:05am ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a medical technolog...

 PRESS RELEASE

Nyxoah Announces Commercial Launch of Genio® Breakthrough Therapy in ...

Nyxoah Announces Commercial Launch of Genio® Breakthrough Therapy in the Middle East Nyxoah Announces Commercial Launch of Genio® Breakthrough Therapy in the Middle EastFirst patient implanted with Genio at Saudi German Hospital in Dubai, United Arab Emirates Mont-Saint-Guibert, Belgium – February 19, 2025, 7:05am CET / 1:05am ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a medical technology company that develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA) through neuromodulation, today announced the commercial launch of its Genio...

 PRESS RELEASE

Publication relating to transparency notifications

Publication relating to transparency notifications                 REGULATED INFORMATION Publication relating to transparency notifications Mont-Saint-Guibert (Belgium), January 20, 2025, 10:30 pm CET / 4:30 pm ET – In accordance with article 14 of the Act of 2 May 2007 on the disclosure of large shareholdings, Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) announces that it received a transparency notification as detailed below. BlackRock, Inc. On January 16, 2025, Nyxoah received a transparency notification from BlackRock, Inc. and related persons. Based on the notification, BlackRock, ...

 PRESS RELEASE

Publication relative à des notifications de transparence

Publication relative à des notifications de transparence         INFORMATION RÉGLEMENTÉE Publication relative à des notifications de transparence Mont-Saint-Guibert (Belgique), le 20 janvier 2025, 22:30h CET / 16:30h ET – Conformément à l'article 14 de la loi du 2 mai 2007 relative à la publicité des participations importantes, Nyxoah SA (Euronext Brussels/Nasdaq : NYXH) annonce qu’elle a reçu une notification de transparence comme détaillé ci-dessous. BlackRock, Inc. Le 16 janvier 2025, Nyxoah a reçu une notification de transparence de BlackRock, Inc. et de personnes liées. Sur la ba...

 PRESS RELEASE

Publication relating to transparency notifications

Publication relating to transparency notifications                 REGULATED INFORMATION Publication relating to transparency notifications Mont-Saint-Guibert (Belgium), December 20, 2024, 10:30 pm CET / 4:30 pm ET – In accordance with article 14 of the Act of 2 May 2007 on the disclosure of large shareholdings, Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) announces that it received a transparency notification as detailed below. BlackRock, Inc. On December 19, 2024, Nyxoah received a transparency notification from BlackRock, Inc. and related persons. Based on the notification, BlackRock,...

 PRESS RELEASE

Publication relative à des notifications de transparence

Publication relative à des notifications de transparence          INFORMATION RÉGLEMENTÉE Publication relative à des notifications de transparence Mont-Saint-Guibert (Belgique), le 20 décembre 2024, 22:30h CET / 16:30h ET – Conformément à l'article 14 de la loi du 2 mai 2007 relative à la publicité des participations importantes, Nyxoah SA (Euronext Brussels/Nasdaq : NYXH) annonce qu’elle a reçu une notification de transparence comme détaillé ci-dessous. BlackRock, Inc. Le 19 décembre 2024, Nyxoah a reçu une notification de transparence de BlackRock, Inc. et de personnes liées. Sur la ...

 PRESS RELEASE

EQS-News: Nyxoah Announces Commercial Launch of Genio® Innovative Ther...

EQS-News: Nyxoah SA. / Key word(s): Market Launch Nyxoah Announces Commercial Launch of Genio® Innovative Therapy in England 13.12.2024 / 08:05 CET/CEST The issuer is solely responsible for the content of this announcement. Nyxoah Announces Commercial Launch of Genio® Innovative Therapy in England First patients implanted with Genio at UCLH, London Mont-Saint-Guibert, Belgium – December 13, 2024, 08:05am CET / 2:05am ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a medical technology company that develops breakthrough treatment alternative...

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