Nyxoah FDA Approval Challenges Inspire in OSA Market

by Victor Pikov, contributing editor

August 2025 issue, BioElectRx Business Report

OSA is a serious health condition affecting an estimated 23 million people in the U.S. If left untreated, it significantly increases the risk of cardiovascular and neurological diseases. The standard treatment is Continuous Positive Airway Pressure, but its effectiveness is limited by low patient compliance, with only about 40% of users sticking with the therapy long-term. For patients who cannot tolerate CPAP, surgical options are available. Historically, this meant traditional airway reconstruction surgery, which has an efficacy rate of 30 to 60%.

However, a newer technology called hypoglossal nerve stimulation has emerged as a much more effective alternative, boasting a 90% success rate. As a result, HNS has become the preferred option for CPAP-intolerant patients, with more than 100,000 devices implanted worldwide, while the number of traditional airway surgeries has plummeted 10-fold.

Until recently, the Inspire V device from Inspire Medical was the only HNS therapy in the U.S. market. This changed on August 8, 2025, when the FDA granted PMA approval to a competing device, the Genio system from Nyxoah SA.

Inspire is a formidable market leader with more than 1,300 employees, 1,500 implanters, $800 million in 2024 revenue, and reimbursement established in all 50 states.

The Nyxoah Genio device has several advantages: lower cost (based on its simpler design), bilateral stimulation unlike Inspire’s unilateral approach, broader patient eligibility, including those with complete concentric collapse, better efficacy in supine position (based on results of their DREAM study), and full-body MRI compatibility at both 1.5T and 3T.

Furthermore, the implantation surgery for the Genio device is faster and less invasive. It requires only a single incision under local anesthesia, compared to the 60 to 90 minute, two-incision surgery under general anesthesia needed for the Inspire V system. Nyxoah can also benefit from the underpenetrated OSA market in the U.S., judged by 2 million annual CPAP prescriptions, and from the inclination of procurement teams at many hospitals to carry two vendors for each therapy for safeguarding against possible supply bottlenecks or FDA recalls.

A key technical difference lies in how the devices operate. Inspire’s system uses a chest sensor to detect a patient’s breathing, timing the nerve stimulation to their inhalation. The current FDA-approved Genio device works in an “open-loop” fashion without a sensor. However, Nyxoah is focused on the future. CEO Olivier Taelman told BBR that “Nyxoah is pioneering minimally invasive neuromodulation to treat OSA, while creating a Genio community ecosystem powered by AI-enabled smart learning devices.” While details are sparse, Nyxoah’s CCO, Jeyakumar Subbaroyan, suggested that future versions of the Genio device will include embedded sensors.

Nyxoah’s biggest immediate challenge is a patent infringement lawsuit filed by Inspire on May 30, 2025. The lawsuit alleges that Nyxoah’s device infringes on three Inspire’s patents (10,898,709, 11,806,52, and 11,850,424) related to the implant design and lead placement.

Inspire is seeking a preliminary injunction to halt Nyxoah’s sales in the U.S. A court may grant this, if Inspire can demonstrate a strong case and show that it would suffer significant harm from the competition. In the meantime, Nyxoah is permitted to proceed with its U.S. launch and build its sales network, while leveraging existing CMS codes that cover the cost of its unibody IPG with embedded electrodes.