Nyxoah Announces 2024 Strategic Priorities

Nyxoah Announces 2024 Strategic Priorities

Mont-Saint-Guibert, Belgium – January 17, 2024, 10:05pm CET / 4:05pm ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA), today announced, in anticipation of upcoming investor meetings, its strategic priorities for 2024.
           
2024 Strategic Priorities

• Complete patient follow up in the DREAM U.S. pivotal study and report efficacy and safety data by early April. 12-month efficacy data¹ 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.
• File the fourth and final module in the modular PMA submission. Anticipate submitting the final module shortly after announcing DREAM results.
• Accelerate investments in the U.S. commercial organization in preparation for a late 2024 launch. Recently hired Francis Kim as Chief Regulatory and Quality Officer and expanded market access to secure reimbursement at launch.
• Complete enrollment in the ACCCESS complete concentric collapse (CCC) U.S. pivotal study. Recently announced investigator-sponsored data in Europe demonstrating Genio’s success in treating CCC patients.
• Increase hypoglossal nerve stimulation (HGNS) market penetration and Genio market share in Europe. For 2024, we expect continued sales growth driven by an increasing benefit from direct-to-consumer (DTC) initiatives, initial contribution from the ResMed commercial partnership in Germany and geographic expansion.
  
  

“Since Nyxoah’s founding we have been guided by the mission to improve the lives of OSA patients. This led to the development of the patient-centric Genio HGNS system. Genio’s single-incision, leadless, upgradable design powered and controlled by a wearable resonated with clinicians and patients and led to a strong European launch. Genio’s bilateral stimulation enables treatment of CCC, and the label was subsequently expanded to include these patients, whose only treatment option after failing CPAP up until then was major palate surgery,” commented Olivier Taelman, Chief Executive Officer.