Nyxoah's Sleep Apnea Implant Receives FDA Approval Amid Patent Dispute

Nyxoah, a Belgium-based medical device company, has received FDA approval for its Genio system, a neuromodulation therapy designed to treat obstructive sleep apnea (OSA). This milestone marks a significant development in the treatment of sleep disorders, offering an alternative to traditional CPAP therapy. However, the company's plans for a U.S. launch face potential legal challenges from competitor Inspire Medical.

FDA Approval and Clinical Efficacy

The Genio system, which has been available in Europe since 2019, has now been cleared for use in patients with moderate to severe OSA. The device consists of a small, battery-free nerve stimulation implant powered by an external device worn during sleep and controlled via a smartphone app. It works by delivering bilateral electric pulses to the hypoglossal nerves, which control tongue muscles, to keep the airway clear during sleep.

In Nyxoah's pivotal trial, the Genio system demonstrated impressive results:

• A median reduction in the apnea-hypopnea index of approximately 71%
• 82% of participants saw their scores improve to at least the mild range
• Efficacy was maintained regardless of sleeping position, a crucial factor given that airway obstructions typically double when sleeping on one's back

Olivier Taelman, CEO of Nyxoah, expressed enthusiasm about the approval, stating, "Today marks a defining moment for Nyxoah and for U.S. patients suffering from OSA. With the FDA's marketing approval of the Genio system, we are proud to bring this innovative therapy to the U.S. market."

Legal Challenges and Market Competition

Despite the FDA approval, Nyxoah's entry into the U.S. market may be complicated by a patent infringement lawsuit filed by rival Inspire Medical on May 30, 2025. Inspire is seeking an injunction in Delaware federal court to prevent Nyxoah from entering the U.S. market, claiming that the Genio system infringes on three of its neurostimulation patents.

Inspire Medical, which received FDA approval for its own sleep apnea neurostimulation device in 2014, has an established presence in the U.S. market. Their system uses a pacemaker-like approach with a pulse generator implanted near the collarbone, connected to the hypoglossal nerves and a breathing sensor.

Nyxoah has stated that it is "well prepared, has the means and intends to vigorously defend itself in this matter." Meanwhile, Inspire Medical faces its own challenges, with an ongoing civil false claims investigation by the Department of Justice regarding reimbursements from Medicare and Medicaid.

Financial Performance and Global Operations

Nyxoah recently released preliminary financial results for the second quarter of 2025, reporting:

• Revenue of 1.3 million euros (approximately $1.5 million USD), a 73% increase over the same period last year
• Operating expenses expected to exceed 20 million euros, a 50% increase

The company also announced a restructuring of its global operations, with plans to transition all ongoing R&D activities from Israel to the U.S. and Belgium. Taelman commented on the company's growth, stating, "We are pleased with the growth we saw in the second quarter, which provides further evidence that our commercial proof of concept in Germany has been successful."

As Nyxoah prepares to enter the U.S. market, it aims to apply the lessons learned from its European operations to its U.S. commercialization strategy. The company's unique Genio system is poised to offer a new option for OSA patients, pending the resolution of the ongoing patent dispute.