Nyxoah Gains FDA Approval for Genio System, Reports 73% Revenue Increase in Q2 2025.

Nyxoah has received FDA approval for its Genio system to treat moderate to severe obstructive sleep apnea in the US. The company reported a 73% increase in revenue in Q2 2025 compared to the previous year, despite a rise in operating expenses. The Genio system utilizes bilateral stimulation and has shown high efficacy in clinical trials. Nyxoah is transitioning its R&D activities to the US and Belgium, indicating a strategic shift in its operations.

Nyxoah SA, a medical technology company focused on Obstructive Sleep Apnea (OSA) treatment, has received a significant regulatory milestone with the U.S. Food and Drug Administration (FDA) approval of its Genio system for treating moderate to severe OSA. The approval opens access to the lucrative U.S. market, potentially transforming Nyxoah's commercial trajectory after demonstrating success in Germany.

In its second quarter of 2025, Nyxoah reported a substantial 73% year-over-year increase in revenue, reaching €1.3 million [2]. This growth validates the company's commercial strategy in Germany. However, the company also reported a 50% increase in operating expenses to €20.7 million, creating a concerning cash burn situation. Nyxoah currently has €43 million in cash and equivalents, with access to an additional €27.5 million in debt facilities, providing approximately 18-24 months of runway at current burn rates [2].

The Genio system, a leadless and battery-free hypoglossal neurostimulation therapy, utilizes bilateral stimulation and has shown high efficacy in clinical trials. The DREAM pivotal trial demonstrated an AHI responder rate of 63.5% and an Oxygen Desaturation Index responder rate of 71.3%, with an overall median AHI reduction of 70.8% [1]. The system's approval represents a major addition to the treatment options available for physicians treating patients with OSA.

Nyxoah's strategic shift includes transitioning its R&D activities to the U.S. and Belgium, indicating a focus on commercialization priorities. The company is also facing a patent infringement lawsuit from Inspire Medical Systems, which may impact its operations. Despite these challenges, Nyxoah's Q2 2025 announcement marks a pivotal moment, setting the stage for potential market expansion and revenue growth in the U.S.

References:
[1] https://www.biospace.com/press-releases/nyxoah-receives-approval-from-fda-for-genio-system-for-the-treatment-of-obstructive-sleep-apnea
[2] https://www.stocktitan.net/news/NYXH/nyxoah-announces-preliminary-results-for-the-second-quarter-of-2wo3dhp148uy.html