Core Viewpoint - Nyxoah has received FDA approval for its Genio system, a novel treatment for obstructive sleep apnea (OSA), marking a significant advancement in the U.S. market for OSA therapies [2][4]. Company Overview - Nyxoah is a medical technology company focused on innovative solutions for OSA, with its lead product being the Genio system, which is a leadless and battery-free hypoglossal neurostimulation therapy [7]. - The company aims to enhance the quality of life for OSA patients by providing effective treatment options [7]. Product Details - The Genio system utilizes bilateral stimulation and is designed to be MRI compatible, offering a non-implanted battery solution controlled by a wearable component [3]. - The wearable component is fully upgradable, allowing patients to access technological advancements without additional surgeries [3]. Clinical Data - The FDA approval was based on the DREAM pivotal trial, which demonstrated a 63.5% AHI responder rate and a 71.3% Oxygen Desaturation Index responder rate, with a median AHI reduction of 70.8% [4]. - Notably, 82.0% of subjects in the DREAM study achieved AHI scores below 15 [4]. - The study also showed efficacy across different sleeping positions, with a median AHI reduction of 66.6% in the supine position, which is significant given the increased airway obstruction risk in that position [5][6]. Market Impact - The approval of the Genio system expands treatment options for physicians managing OSA, particularly due to its consistent efficacy across various sleeping positions [6]. - The company is poised to execute its U.S. commercialization strategy following this approval [4].