Nyxoah SA announced today that the U.S. Food and Drug Administration (FDA) has issued an Approvable Letter for the company's Genio system, a novel treatment for Obstructive Sleep Apnea (OSA). This regulatory milestone brings the patient-centered, leadless and battery-free hypoglossal neurostimulation therapy one step closer to the U.S. market.
The Approvable Letter signifies that Nyxoah's Pre-Market Approval (PMA) application substantially meets the requirements of the Federal Food, Drug and Cosmetic Act and the FDA's implementing regulations. Final approval is now subject only to satisfactory completion of a manufacturing facilities, methods and controls review.
"The FDA has reviewed our submission and determined that it substantially meets the requirements for approval," said Olivier Taelman, Nyxoah's Chief Executive Officer. "The FDA's Approvable Letter included no further questions on the clinical data or biocompatibility that support the submission. We are still on the right track to make Genio available to U.S. patients suffering from OSA."
The Genio System and OSA Treatment Landscape
Obstructive Sleep Apnea affects millions worldwide and is associated with increased mortality risk and cardiovascular comorbidities. The condition, characterized by repeated breathing interruptions during sleep, has traditionally been treated with continuous positive airway pressure (CPAP) therapy, but patient compliance remains a significant challenge.
The Genio system represents a significant advancement in OSA treatment technology. As a leadless and battery-free device, it offers distinct advantages over existing neurostimulation therapies. The system works by delivering mild stimulation to the hypoglossal nerve, which controls tongue movement, helping to maintain an open airway during sleep.
Regulatory and Clinical Development Path
Nyxoah's journey toward U.S. approval has been supported by robust clinical evidence. The company previously announced positive outcomes from its DREAM IDE pivotal study, which provided key data for the PMA submission.
In Europe, the Genio system received CE Mark approval in 2019 following the successful completion of the BLAST OSA study. The company later expanded its European therapeutic indications to include Complete Concentric Collapse (CCC) patients based on positive outcomes from the BETTER SLEEP study. This expanded indication is particularly significant as CCC patients are currently contraindicated in competitors' therapies.
Market Position and Company Background
Nyxoah has established itself as an emerging player in the sleep apnea treatment market. The company completed two successful IPOs: on Euronext Brussels in September 2020 and NASDAQ in July 2021, providing capital to advance its clinical and commercial objectives.
The company emphasizes that the FDA's decision does not impact Genio's CE Mark or ongoing commercial activities in Europe, where the device continues to be available for both CCC and non-CCC patients.
Next Steps Toward U.S. Market Entry
Nyxoah will now work closely with the FDA to address the remaining requirements related to manufacturing facilities, methods, and controls. The company has expressed commitment to bringing this innovative therapy to U.S. patients as soon as possible.
The Genio system remains an investigational device in the United States, limited by federal law to investigational use until final FDA approval is secured.
For OSA patients seeking alternatives to conventional therapies, the advancement of the Genio system through the regulatory process represents a promising development in expanding treatment options for this common and serious sleep disorder.
