-
Posted by
Two Blokes Wed at 6:15 AM -
Filed in
Stock
-
2 views
REGULATED INFORMATION 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 the “Company”), a medical technology company that develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA) through neuromodulation, today reported financial and operating results for the first quarter of 2025. Recent Financial and Operating Highlights Received an FDA Approvable Letter indicating the FDA will approve the Company's PMA application for its Genio\u00ae system subject to satisfactory completion of a manufacturing facilities, methods and controls review Successfully completed FDA validation requirements, final site inspection in progress at the U.S. contract manufacturing site Revenue for the first quarter of 2025 was €1.1 million, compared to €1.2 million in the first quarter of 2024 Launched Genio\u00ae 2.1 patient software upgrade in international commercial markets Cash, cash equivalents and financial assets were €63.0 million at March 31, 2025, compared to €85.6 million at the end of 2024 "We are excited that we are in the final stage of the FDA review process of our Genio\u00ae system in the United States," commented Olivier Taelman, Nyxoah's Chief Executive Officer.
