Nyxoah (NYXH) investor relations material

Technology and product differentiation

• Introduced a next-generation neuromodulation solution for obstructive sleep apnea (OSA) using bilateral hypoglossal nerve stimulation and a single-incision, battery-free implant.

• Wearable component contains the battery and software, allowing remote software upgrades and eliminating the need for re-surgery.

• Full body MRI compatibility and ease of use for both patients and physicians are key features.

• Demonstrated unique efficacy in positional OSA, maintaining airway opening regardless of sleep position.

• Platform enables future innovation, including patient feedback apps and potential for fully integrated, invisible implants.

Clinical evidence and regulatory milestones

• DREAM pivotal study met all primary and secondary endpoints, showing a median 70% reduction in apnea events and 82% of patients achieving AHI below 15.

• Demonstrated safety with a lower severe event rate (8.7%) compared to competitors.

• Only device with proven efficacy in positional OSA and no contraindication for complete concentric collapse (CCC) in the U.S. label.

• Access trial for CCC patients completed enrollment, aiming for U.S. label expansion by early 2027.

Commercial strategy and U.S. launch

• U.S. approval received in August, with immediate commercial launch and a team of 50-55, including 25 territory managers.

• Focused on high-volume implanting sites, targeting 400 key accounts representing 80% of the market.

• Two-pronged approach: engaging both ENT surgeons and sleep physicians, with emphasis on education and post-surgery management.

• Early indicators include number of surgeons trained, value analysis committee approvals, and preauthorizations.

• Initial rollout concentrated in East Coast, Texas, and Midwest hotspots based on referral networks and committee speed.