Nyxoah SA. · ISIN: BE0974358906 · EQS - Company News

Nyxoah Receives Approval from FDA for Genio® System for the Treatment of Obstructive Sleep Apnea

Nyxoah Receives Approval from FDA for Genio® System for the Treatment of Obstructive Sleep Apnea U.S. Commercialization Officially Launched Mont-Saint-Guibert, Belgium – August 8, 2025, 11:30pm CET / 5:30pm 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 that the U.S. Food and Drug Administration (FDA) has appro...

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Corporate News Nyxoah SA.

In this overview you can view company news in the chronological order of publication. The source information comes from EQS News, the leading European news distributor. The most recent news item is listed first.
08 August 2025 11:30PM
Nyxoah Receives Approval from FDA for Genio® System for the Treatment of Obstructive Sleep Apnea
Nyxoah Receives Approval from FDA for Genio® System for the Treatment of Obstructive Sleep Apnea U.S. Commercialization Officially Launched Mont-Saint-Guibert, Belgium – August 8, 2025, 11:30pm CET / 5:30pm ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”),  a medical technology company that develops breakthrough treatm...
Nyxoah SA.
28 July 2025 10:05PM
Nyxoah’s DREAM Pivotal Study Data Published in the Journal of Clinical Sleep Medicine
Nyxoah’s DREAM Pivotal Study Data Published in the Journal of Clinical Sleep Medicine Mont-Saint-Guibert, Belgium – July 28, 2025, 10:05pm CET / 4:05pm 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), today ...
Nyxoah SA.
14 May 2025 07:00AM
Nyxoah Reports First Quarter Financial and Operating Results
Nyxoah Reports First Quarter Financial and Operating Results  Company On Track for Anticipated PMA Approval in the Second Quarter of 2025 Successfully Completed FDA Validation Requirements, Final Site Inspection in Progress  Mont-Saint-Guibert, Belgium – May 14, 2025, 7am CET / 1am ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or th...
Nyxoah SA.
08 April 2025 07:00AM
Nyxoah Provides Update on FDA Approvable Letter for Genio System
 Nyxoah Provides Update on FDA Approvable Letter for Genio System Expects to meet final FDA requirements for full PMA approval in the second quarter Mont-Saint-Guibert, Belgium – April 8, 2025, 7:00am CET / 1:00am ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), which develops breakthrough treatment alternatives for O...
Nyxoah SA.
26 March 2025 09:45AM
FDA Issues Nyxoah an Approvable Letter for its Genio® System
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 a...
Nyxoah SA.
13 March 2025 07:00AM
Nyxoah Reports Fourth Quarter and Financial Year 2024 Financial and Operating Results
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”), that dev...
Nyxoah SA.
19 February 2025 07:05AM
Nyxoah Announces Commercial Launch of Genio® Breakthrough Therapy in the Middle East
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 technology comp...
Nyxoah SA.
13 December 2024 08:05AM
Nyxoah Announces Commercial Launch of Genio® Innovative Therapy in England
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 alterna...
Nyxoah SA.
06 November 2024 10:05PM
Nyxoah Reports Third Quarter Financial and Operating Results
Nyxoah Reports Third Quarter Financial and Operating Results  FDA approval on track for first quarter 2025, U.S. commercial team build out in progress Company fully funded with cash until mid 2026 Mont-Saint-Guibert, Belgium – November 6, 2024, 10:05pm CET / 4:05pm ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a me...
Nyxoah SA.
08 October 2024 02:00PM
Nyxoah Raises $27 Million through its At-the-Market Offering
Nyxoah Raises $27 Million through its At-the-Market Offering  Investment by a new U.S.-based healthcare investor, strengthening the balance sheet and reinforcing U.S. focus Mont-Saint-Guibert, Belgium – October 8, 2024 – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a medical technology company that develops breakthroug...
Nyxoah SA.
27 September 2024 10:30PM
DREAM Pivotal Study Data Presented at the International Surgical Sleep Society 2024 Educational Update
DREAM Pivotal Study Data Presented at the International Surgical Sleep Society 2024 Educational Update Additional clinical data on patients suffering from Obstructive Sleep Apnea (OSA) demonstrate a clinically significant 71.0% median reduction in Apnea-Hypopnea index (AHI) while sleeping supine at 12 months compared with baseline. 82.0% of patie...
Nyxoah SA.
02 September 2024 10:05PM
Nyxoah Rings the Closing Bell at Nasdaq while Preparing for U.S. Market Launch of Innovative Sleep Apnea Device
Nyxoah Rings the Closing Bell at Nasdaq while Preparing for U.S. Market Launch of Innovative Sleep Apnea Device FDA regulatory submission for the Company’s Genio® device is complete, U.S. approval on track for the end of 2024 U.S. commercial launch, expected at the beginning of 2025, fully funded with over €85 million in new capital raised Mont...
Nyxoah SA.
06 August 2024 10:05PM
Nyxoah Reports Second Quarter and First Half 2024 Financial and Operating Results
Nyxoah Reports Second Quarter and First Half 2024 Financial and Operating Results FDA regulatory submission complete, U.S. approval on track for end of 2024 U.S. commercial launch fully funded with over €85 million in new capital raised Mont-Saint-Guibert, Belgium – August 6, 2024 10:05pm CET / 4:05pm ET – Nyxoah SA (Euronext Brussels/Nasdaq: NY...
Nyxoah SA.
15 July 2024 08:15AM
Nyxoah Appoints Scott Holstine as Chief Commercial Officer
Nyxoah Appoints Scott Holstine as Chief Commercial Officer Mont-Saint-Guibert, Belgium – July 15, 2024, 8:00am CET / 2:00am ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA), today ...
Nyxoah SA.
03 July 2024 12:30PM
Nyxoah Has Signed a €37.5 Million Loan Facility Agreement with the European Investment Bank
Nyxoah Has Signed a €37.5 Million Loan Facility Agreement with the European Investment Bank Mont-Saint-Guibert, Belgium – July 3, 2024, 12:30pm CET / 6:30am ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a medical technology company focused on the development and commercialization of innovative solutions to treat Obst...
Nyxoah SA.
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