Summary: The US FDA has approved Nyxoah SA’s Genio hypoglossal nerve stimulator for adults with moderate to severe OSA (AHI 15–65). Genio delivers bilateral stimulation via a leadless, MRI-compatible design powered by an upgradable wearable, eliminating the need for surgical battery replacements.
Key takeaways:
- The Genio wearable controller is upgradable, avoiding additional surgeries for technology or battery updates.
- DREAM pivotal trial showed consistent efficacy across sleeping positions, including the challenging supine position.
- Nyxoah aims to replicate Germany’s commercialization success in the US and expand evidence in complete concentric collapse patients through the ACCCESS study.
The US Food and Drug Administration (FDA) has approved Nyxoah SA’s Genio neurostimulator system for a subset of patients with moderate to severe obstructive sleep apnea (OSA) with an apnea-hypopnea index (AHI) of greater than or equal to 15 and less than or equal to 65.
A hypoglossal nerve stimulator for the treatment of OSA, Genio’s design utilizes bilateral stimulation and offers a leadless, full-body 1.5T and 3T MRI-compatible, non-implanted battery solution that is powered and controlled by a wearable component.
The wearable component is upgradable, providing Genio patients with access to this technology without requiring additional surgeries for technology updates or battery replacements.
“With the FDA’s marketing approval of the Genio system, we are proud to bring this innovative therapy to the US market,” says Olivier Taelman, Nyxoah’s CEO, in a release. “Our mission has always been to make sleep simple for OSA patients by offering them a solution that empowers better sleep. We look forward to the successful execution of our US commercialization strategy.”
The Genio system’s FDA approval was supported by the company’s DREAM pivotal trial. According to the DREAM study, Genio is efficacious regardless of a patient’s sleeping position. According to Nyxoah management, this is a critical differentiator as, on average, people sleep in a supine position between 35% and 40% of the night. The DREAM study measured position-specific outcomes and demonstrated a 66.6% median AHI reduction while patients slept in a supine position despite the fact that the number of airway obstructions can double in this position. This reduction compares favorably to the 71.0% reduction in AHI shown while patients slept in a non-supine position.
“The Genio system’s approval represents a major addition to the treatment options available to physicians treating patients with OSA,” says Colin T. Huntley, MD, an associate professor in the Department of Otolaryngology Head & Neck Surgery at Thomas Jefferson University, in a release. “This unique bilateral stimulation technology has demonstrated consistent efficacy across all sleeping positions, including the challenging supine position, while maintaining an excellent safety profile.”
The company’s commercial proof of concept in Germany has been successful, Taelman says. “With FDA approval in hand, we expect to take the lessons learned from Germany and apply them to the US as we bring our unique Genio system to the US. In addition, we believe that the patient population currently enrolled in the ACCCESS study will provide statistically significant results, which, along with the outcomes from prior clinical evidence, will provide meaningful data with respect to the safety and efficacy of using Genio therapy in the patient population suffering from complete concentric collapse (CCC).”
