Nyxoah Rings the Closing Bell at Nasdaq while Preparing for U.S. Market Launch of Innovative Sleep Apnea Device

EQS-News: Nyxoah SA. / Key word(s): Miscellaneous Nyxoah Rings the Closing Bell at Nasdaq while Preparing for U.S. Market Launch of Innovative Sleep Apnea Device 02.09.2024 / 22:05 CET/CEST The issuer is solely responsible for the content of this announcement. 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-Saint-Guibert, Belgium – September 2, 2024 10:05pm CET / 4:05PM 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), rang the Nasdaq Closing Bell on August 29, 2024 to recognize the Company’s recent progress and highlight upcoming milestones on its path to the U.S. market launch of its innovative patient-centric Genio hypoglossal nerve stimulation technology for OSA, a prevalent and severe sleep-related breathing disorder associated with increased mortality risk and cardiovascular comorbidities.

“We are honored to ring the Closing Bell and to celebrate our recent clinical and regulatory achievements in the U.S. We look forward with excitement to the upcoming U.S. launch of our lead product, Genio,” commented Olivier Taelman, Nyxoah’s Chief Executive Officer. “The U.S. is the largest healthcare market globally and therefore of strategic importance for us. With robust clinical evidence from our pivotal DREAM study, solid funding in place and our strengthened US commercial team, we feel well positioned to enter the US market. We have submitted the final module of our PMA submission to the FDA and are on track for U.S. approval by the end of 2024. If approved, Genio could become available in the U.S. as early as the beginning of 2025.”