Nyxoah (NYXH) investor relations material

Market opportunity and positioning

• Obstructive sleep apnea (OSA) represents a $10B annual U.S. market, with significant underpenetration and rapid growth potential.

• The company is the second player in the U.S. HGNS market, targeting both U.S. and international expansion.

• Over 2,000 patients have been treated globally, with commercial reimbursement established in the U.S., Germany, UK, Netherlands, and the Middle East.

• FDA approval was secured in August 2025, and a dedicated U.S. commercial team is actively launching the product.

• U.S. reimbursement is supported by existing CPT codes for private payers and a dedicated C-code for CMS.

Technology and product differentiation

• The Genio system offers bilateral hypoglossal nerve stimulation, a unique patient-first approach with no implanted battery and full-body MRI compatibility.

• The system is powered externally via a smart wearable, allowing intelligent control and data capture.

• An intuitive app enables patients to monitor sleep, personalize stimulation, and improve compliance.

• Genio is positioned as an alternative to CPAP, mandibular devices, and traditional surgery, addressing compliance and efficacy limitations of existing therapies.

Clinical evidence and regulatory milestones

• The DREAM pivotal study demonstrated safety and efficacy, achieving co-primary endpoints with a 70.8% median AHI reduction at 12 months.

• 82% of patients achieved AHI below 15 at 12 months, with a serious adverse event rate of 8.7%.

• The ACCCESS study for CCC patients met safety and efficacy endpoints, supporting U.S. label expansion.

• Genio is approved for CCC patients in Europe since 2021 and is preparing for U.S. indication expansion.