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

Company overview and technology

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

• Utilizes bilateral stimulation to maintain airway patency regardless of sleep position or type of obstruction.

• Differentiates with a single-incision procedure, enhancing safety and patient experience.

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 clinical site visit in Belgium scheduled for early January.

• Achieved primary efficacy and safety endpoints, with 82.8% of patients reducing AHI below 15, lowering cardiovascular risk.

• Journal acceptance of pivotal data anticipated by year-end, with publication to follow.

Labeling and market access

• Negotiating with FDA to include supine efficacy data and avoid contraindication for complete concentric collapse (CCC) patients in the initial label.

• Ongoing ACCESS study aims for future label expansion to include CCC claim, aligning with the European label by mid-2026.

• Confident in FDA openness to label differentiation based on clinical data.