Nyxoah (NYXH) Jefferies 2024 Global Healthcare Conference summary

Market opportunity and competitive landscape

• Over 900 million people globally suffer from obstructive sleep apnea, with 500,000 eligible for hypoglossal nerve stimulation in the U.S.

• Only 30,000 U.S. patients have received this treatment, with one company currently holding a monopoly.

• Up to 50% of CPAP users quit within two years, highlighting the need for alternatives.

• Market research indicates strong physician demand for a second provider, with expectations of a 50/50 market split over time.

• In Germany, market share reached 50% within 24 months of launch, confirming demand for alternatives.

Technology and patient benefits

• Genio system offers bilateral stimulation without an implantable battery or leads, reducing invasiveness and risk.

• Single-incision, 60-minute outpatient procedure with minimal scarring and full-body MRI compatibility.

• Wearable activation chip enables cloud-based software updates and immediate patient feedback via an app.

• Compliance rate of 87% measured as use for at least five nights per week, five hours per night.

• Genio is effective for patients with complete concentric collapse, a group contraindicated for the main competitor.

Clinical results and regulatory progress

• DREAM IDE study in the U.S. met all primary and secondary endpoints, including safety.

• Genio maintains airway patency and AHI reduction regardless of sleep position, outperforming competitors in supine position (70.8% vs. 40-45%).

• Adverse event rate is 8.7%, significantly lower than the main competitor's 34%.

• Over 500 patients implanted in Europe, with the longest follow-up approaching five years.

• FDA approval expected by end of year, with all but the final PMA module submitted.