Nyxoah (NYXH) Piper Sandler 36th Annual Healthcare Conference summary

Company overview and technology

• Focuses on obstructive sleep apnea with an innovative neuromodulation implant powered externally, offering full-body MRI approval and Bluetooth upgrades.

• Utilizes bilateral stimulation, maintaining airway patency regardless of sleep position or type of obstruction.

• Emphasizes patient-centered simplicity and differentiation from competitors through single-incision procedures.

Regulatory and clinical milestones

• Closed pivotal study in March and presented data at ISSS in September, receiving strong positive feedback.

• Expects FDA approval in Q1 2025, pending a final Belgian clinical site visit rescheduled for early January.

• Label negotiations with FDA focus on including supine data and removing contraindications for complete concentric collapse (CCC) patients.

Clinical data and differentiation

• Achieved primary efficacy endpoints with over 50% reduction in apnea/hypopnea events and strong safety profile (8.7% severe adverse events vs. 21.7% for competitors).

• Demonstrated consistent efficacy across all sleep positions and significant reduction in cardiovascular risk, with 82.8% of patients achieving AHI below 15.

• Journal publication acceptance expected by year-end, with publication to follow.