Nyxoah SA, maker of the CE-marked Genio neurostimulator for the treatment of obstructive sleep apnea (OSA), outlined its strategic goals for 2024, focusing on pivotal study completions, regulatory submissions, and market expansion. 

By early April, Nyxoah aims to complete patient follow-up in the DREAM US pivotal study and report efficacy and safety data. Twelve-month efficacy data on the first 34 DREAM patients and safety data on all DREAM patients were presented at SLEEP 2023, demonstrating a 65% AHI responder rate, a 76% ODI responder rate, and safety in line with expectations. These data are preliminary and not conclusive of final DREAM success.

The company also plans to file the fourth and final module in the modular Premarket Approval (PMA) submission to the US Food and Drug Administration shortly after announcing DREAM results.

Nyxoah intends to accelerate investments in the US commercial organization in preparation for a late 2024 launch. The company recently hired Francis Kim as chief regulatory and quality officer and expanded market access to secure reimbursement at launch.

Nyxoah also plans to complete enrollment in the ACCCESS complete concentric collapse (CCC) US pivotal study. Nyxoah recently announced investigator-sponsored data in Europe demonstrating Genio’s success in treating CCC patients.

Finally, the company looks to increase hypoglossal nerve stimulation market penetration and Genio market share in Europe. For 2024, Nyxoah says in a release that it expects continued sales growth driven by an increasing benefit from direct-to-consumer initiatives, initial contribution from the ResMed commercial partnership in Germany, and geographic expansion.

“We are now on the cusp of the most significant milestone in the company’s history with the reporting of DREAM results in the coming months. We expect to complete the PMA submission shortly after and are accelerating manufacturing and commercial investments to ensure we are fully prepared to replicate our European success in the US. With an approaching US launch and continued growth in Europe, we are excited for the coming years,” says Olivier Taelman, CEO of Nyxoah in a release. 

Photo 297516307 | 2024 Goals © Andrii Yalanskyi | Dreamstime.com