Nyxoah (NYXH) investor relations material

Market opportunity and positioning

• Obstructive sleep apnea represents a $10B annual U.S. market, underpenetrated and rapidly growing, with entry as the second market player disrupting a single-company dynamic.

• Over 1,000 patients treated in Europe, with commercial reimbursement in Germany, UK, Netherlands, and UAE.

• FDA approval achieved in August 2025, with U.S. reimbursement secured from CMS and major private payers.

• Commercial success demonstrated internationally, with a strong U.S. launch and momentum.

Technology and product differentiation

• Genio system offers bilateral nerve stimulation, no implanted battery, and full-body MRI compatibility.

• Smart wearable and intuitive app enable external power, personalized stimulation, and patient-driven compliance.

• Differentiated as a patient-first technology, providing an alternative to limited existing OSA treatments.

Clinical evidence and safety

• DREAM pivotal study met safety and efficacy endpoints, with 70.8% median AHI reduction at 12 months and 82% of patients achieving AHI below 15.

• Serious adverse event rate was 8.7%, with most common events being application site irritation and dysphagia.

• Study design included 115 patients, with independent adjudication of safety events.