Company Overview - Nyxoah (NYXH) received FDA approval for its Genio system, an innovative therapy for moderate to severe Obstructive Sleep Apnea (OSA) featuring a leadless, battery-free design powered by an upgradable wearable [1][8] - The Genio system utilizes a unique bilateral nerve stimulation approach, now launching in the U.S. market [1][3] Clinical Trial Results - The FDA approval was supported by the DREAM pivotal trial, which achieved a 63.5% apnea-hypopnea index (AHI) responder rate and a 71.3% Oxygen Desaturation Index (ODI) responder rate, with a median AHI reduction of 70.8% [4] - Notably, 82% of participants saw their AHI drop below 15, demonstrating Genio's efficacy across all sleeping positions [4][5] Product Features - Genio's design is MRI compatible (1.5T and 3T), making it more convenient and less invasive for patients [3] - The system is powered and controlled by a wearable component, which is fully upgradable, allowing for technology updates without additional surgeries or battery replacements [3][5] Market Prospects - The global sleep apnea devices market was estimated at $4.5 billion in 2023 and is projected to reach $6.9 billion by 2030, with a CAGR of 6.2% from 2024 to 2030 [6] - Key growth drivers include a growing geriatric population, a significant patient pool with sleep apnea, and the development of advanced devices [6] Competitive Landscape - Nyxoah competes with several innovative players in the sleep apnea treatment market, including Inspire Medical Systems, ResMed, and LivaNova, all of which are developing advanced therapies and devices [7][10][11] - Inspire Medical Systems launched its Inspire V neurostimulation system, which features a 20% reduction in implant time and Bluetooth-enabled connectivity [7][9] - ResMed introduced its AirSense 11 CPAP device with advanced capabilities to enhance patient adherence and clinician access [10] - LivaNova reported a 65% responder rate in its OSPREY trial for its aura6000 proximal hypoglossal nerve stimulator, indicating sustained efficacy [11]

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].