Nyxoah Announces Preliminary Results for the Second Quarter of 2025

Core Viewpoint - Nyxoah has reported preliminary financial results for Q2 2025, indicating significant growth and successful commercial proof of concept in Germany, with plans to expand into the U.S. market following FDA approval of its Genio system [1][3]. Financial Results - Revenue for Q2 2025 is anticipated to be approximately €1.3 million, representing a 73% increase compared to Q2 2024 [4]. - Operating expenses for Q2 2025 are expected to be around €20.7 million, a 50% increase from Q2 2024 [4]. - Cash, cash equivalents, and financial assets are projected to be approximately €43.0 million as of June 30, 2025 [4]. Business Updates - The Genio system has received FDA approval for a subset of adult patients with moderate to severe Obstructive Sleep Apnea (OSA), specifically those with an Apnea-Hypopnea Index (AHI) between 15 and 65 [4][6]. - The company plans to close patient enrollment in its ACCCESS clinical trial, which aims to assess the safety and efficacy of Genio therapy for patients suffering from Complete Concentric Collapse (CCC) [4]. - Nyxoah has reorganized its global R&D function, transitioning ongoing activities from Israel to the U.S. and Belgium [4]. Legal Matters - Inspire Medical Systems, Inc. has filed a lawsuit against Nyxoah in the U.S. for alleged patent infringement, and the company intends to vigorously defend itself [4].