Nyxoah (NYXH) Baird's 2024 Global Healthcare Conference summary

Market overview and technology differentiation

• Obstructive sleep apnea is a large, under-penetrated market with significant health risks if untreated.

• Genio technology offers bilateral hypoglossal nerve stimulation, no implantable battery, and no leads, differentiating it from competitors.

• Bilateral stimulation allows treatment of complete concentric collapse, expanding patient eligibility.

• The device is MRI-compatible and allows for non-surgical software upgrades.

Clinical data and regulatory progress

• The DREAM pivotal study met primary endpoints for efficacy and safety, with a 63.5% reduction in AHI and 71% response rate for oxygen desaturation.

• Supine sleep efficacy is a key differentiator, as Genio maintains airway patency regardless of sleep position.

• All PMA modules have been submitted, with FDA approval expected by year-end.

• No deficiencies found in site visits; U.S. commercialization is on track.

Commercialization strategy and market entry

• U.S. commercial leadership is in place, with sales reps to be hired and trained by year-end.

• Initial focus will be on 75-100 high-volume implant centers, expanding quarterly.

• Commercial team will start with 50 people, scaling as new sites are added.

• Strategy prioritizes depth of penetration at each site over rapid expansion to many sites.