Nyxoah SA has filed a patent infringement lawsuit against Inspire Medical Systems, Inc., alleging that Inspire's IV and V devices infringe three patents held by the Belgian medical technology company. The lawsuit, filed on September 15, 2025, in the United States District Court for the District of Delaware, seeks injunctive relief and damages for the alleged infringement of U.S. Patent Nos. 8,700,183, 9,415,215, and 9,415,216.
Patent Dispute Centers on Sleep Apnea Technology
The legal action represents a significant development in the competitive landscape for obstructive sleep apnea (OSA) treatments, as both companies develop hypoglossal neurostimulation therapies for this condition. Nyxoah's Chief Executive Officer Olivier Taelman emphasized the company's commitment to defending its intellectual property portfolio, stating, "We will defend our intellectual property portfolio and the proprietary, minimally invasive Genio® system, which does not rely on traditional pacemaker hardware but is a differentiated solution offering bi-lateral stimulation, full body MRI compatibility and an upgradable technology platform that does not require re-surgery for battery replacements."
Genio System's Competitive Advantages
Nyxoah's Genio system represents a patient-centered, leadless and battery-free hypoglossal neurostimulation therapy for OSA, which the company describes as the world's most common sleep disordered breathing condition associated with increased mortality risk and cardiovascular comorbidities. The system's design differentiates it from competitors through several key features, including bilateral stimulation capabilities, full body MRI compatibility, and an upgradable technology platform that eliminates the need for re-surgery when battery replacements are required.
Recent FDA Approval and Commercial Launch
The Genio system received U.S. FDA approval in August 2025 following positive outcomes from the DREAM IDE pivotal study. This approval came after the system had already received European CE Mark approval in 2019 following the successful completion of the BLAST OSA study. The company has also expanded its therapeutic indications to include Complete Concentric Collapse (CCC) patients following positive outcomes from the BETTER SLEEP study, addressing a patient population currently contraindicated in competitors' therapy.
Taelman noted positive early reception of the system, commenting, "We're excited about the positive feedback we have received from both physicians and patients in the first month post-US commercial launch and look forward to introducing the Genio system to more physicians and OSA patients so they can choose the best solution for their needs."
Company Background and Market Position
Nyxoah completed two successful IPOs, listing on Euronext Brussels in September 2020 and NASDAQ in July 2021. The company positions itself as focused on putting patients first and offering physicians alternatives in OSA treatment, trusting healthcare providers to make optimal decisions for their patients suffering from the condition.
The lawsuit underscores the competitive dynamics in the growing sleep apnea device market, where intellectual property protection plays a crucial role in maintaining competitive advantages for innovative medical technologies.
