Nyxoah (NasdaqGM:NYXH) FY Conference Transcript

Nyxoah FY Conference Summary Company Overview - Company: Nyxoah (Ticker: NYXH) - Industry: Medtech, specifically focused on neurostimulation solutions for obstructive sleep apnea (OSA) - Recent Milestone: Obtained FDA approval in August 2025, actively launching products in the U.S. market [2][30] Market Opportunity - Addressable Market: Approximately 450,000-500,000 eligible patients in the U.S. for Genio technology, representing a market opportunity of around $10 billion [3] - Market Penetration: Currently, only 8% of the eligible patient population receives therapy, indicating a largely underpenetrated market [3] Product and Technology - Genio Technology: A differentiated, patient-first neurostimulation device with a unique bilateral mode of action [3][10] - Clinical Evidence: Robust clinical data from the DREAM study, showing efficacy in reducing Apnea-Hypopnea Index (AHI) and oxygen desaturation index [18] - Patient Compliance: Recorded over 87% compliance and 92% patient satisfaction [15] Treatment Landscape - Current Treatment Options: - CPAP (Continuous Positive Airway Pressure) is the gold standard but has a high quit rate (50% annually) [7][8] - Mandibular advancement devices have low predictability and high out-of-pocket costs [7] - Traditional surgery is invasive with a low success rate (30%-60%) [9] - Unilateral hypoglossal nerve stimulation has limitations due to battery implantation [10] Clinical Outcomes - Efficacy Results: - Median AHI reduction of over 70% after 12 months [20] - 82% of patients had AHI below 15, equating their morbidity risk to non-OSA individuals [20] - Safety Profile: Serious adverse event rate of 8.7%, lower than the average for neuromodulation solutions [18][19] Commercial Strategy - Market Entry: Successfully captured 25% market share in Germany within 24 months without direct-to-consumer marketing [21] - U.S. Market Focus: Targeting high-volume ENT surgeons and collaborating with sleep physicians for patient referrals [22][23] - Reimbursement Strategy: Established CPT code 64568, achieving 100% acceptance of pre-authorization files from major payers [25][36] Future Outlook - Expansion Plans: Focus on U.S. market while selectively expanding in Europe and UAE [40] - Clinical Studies: Ongoing trials for Complete Concentric Collapse (CCC) patients, with results expected in June 2026 [27][37] - Technological Advancements: Plans to enhance the wearable component and explore additional nerve stimulation options [38][39] Key Takeaways - Nyxoah is positioned to disrupt the OSA treatment market with its innovative Genio technology, backed by strong clinical evidence and a clear commercial strategy - The company is focused on expanding its market presence in the U.S. while maintaining a commitment to patient-first technology and improving treatment outcomes [28][29]