Nyxoah (NYXH) investor relations material

Market opportunity and value creation

• Obstructive sleep apnea represents a $10 billion U.S. market with 450,000–500,000 eligible patients and low current penetration.

• Genio technology offers a differentiated, patient-first solution with bilateral neurostimulation and robust clinical evidence.

• The company is actively launching in the U.S. after FDA approval and has secured reimbursement from both private payers and CMS.

• International presence established in Germany, U.K., Netherlands, and UAE, with over 1,000 patients treated outside the U.S.

• Commercial strategy focuses on high-volume ENT centers and collaboration with sleep physicians.

Technology and clinical evidence

• Genio system features a passive implantable stimulator and a smart wearable, offering full-body MRI compatibility and no implanted battery.

• Minimally invasive, single-incision procedure with rapid recovery and an intuitive app for patient monitoring and personalization.

• Clinical pivotal DREAM study met primary and secondary endpoints, showing 64%+ efficacy and 8.7% serious adverse event rate.

• Median AHI reduction over 70% at 12 months; 82% of patients achieve AHI below 15, normalizing morbidity risk.

• High compliance (87%) and patient satisfaction (92%) reported.

Commercialization and reimbursement

• Achieved 25% market share in competitive German centers within 24 months without direct-to-consumer investment.

• U.S. launch leverages a dedicated commercial team, targeting 400 high-volume sites and scaling territory managers quarterly.

• Reimbursement de-risked with CPT code 64568, 100% pre-authorization acceptance from major private payers and CMS.

• First U.S. quarter saw $4.5 million in sales and training of nearly 150 surgeons.