Company Overview - Nyxoah is a medtech company focused on neurostimulation solutions for obstructive sleep apnea, listed on Nasdaq and Euronext under the ticker NYXH [2] - The company has recently obtained FDA approval for its product, marking a significant milestone in its history [2] Market Opportunity - The addressable market for obstructive sleep apnea in the U.S. is estimated to include 450,000 to 500,000 eligible patients, representing a market opportunity of approximately $10 billion [3] - The market is largely underpenetrated, with only 8% of the total eligible patient population currently receiving therapy [4]

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]

Nyxoah FY Conference Summary Company Overview - **Company**: Nyxoah (NasdaqGM:NYXH) - **Industry**: Medical Technology, specifically focused on hypoglossal nerve stimulation for obstructive sleep apnea (OSA) Key Points U.S. Launch Status - Nyxoah received FDA approval on August 8, 2025, and began its U.S. launch on August 11, 2025 - As of early December, the company has focused on high-volume hypoglossal nerve stimulation accounts, covering approximately 125 out of 400 targeted accounts, which represent about 75% of U.S. revenue volume [6][10] - The company has trained 128 surgeons and submitted 108 pre-market approval (PMA) submissions, with a 100% approval rate for pre-authorizations from private payers and CMS [9][10] Sales Force Expansion - Nyxoah has added 15 territory managers, increasing the total to 40, which will allow the company to target an additional 75 high-volume implant accounts [10][21] - The commercial organization now consists of 50 people, including market access personnel and field engineers [19][20] Financial Guidance and Market Share - For Q4 2025, Nyxoah provided revenue guidance of EUR 3.4 million to EUR 3.6 million [23] - The U.S. H&S market is projected to be around $1 billion in 2026, with Nyxoah aiming for a market share significantly higher than the 3% initially suggested, potentially reaching 15%-25% in focused accounts [24][25] Patient Outcomes and Data Collection - Early feedback from surgeons on patient outcomes post-implantation has been positive, with successful airway openings observed [27][29] - Nyxoah is required to conduct a post-PMA study to follow up on patients, which will also help in developing health economic data [29] Reimbursement Updates - A significant reimbursement change effective January 1, 2026, will increase facility fees for CPT code 64568 by 40%-50%, which is expected to encourage more hospitals to adopt hypoglossal nerve stimulation [30][31] - Nyxoah plans to observe the market dynamics and will not deviate from its focused launch strategy despite the reimbursement changes [32] Long-term Reimbursement Strategy - Nyxoah anticipates the establishment of a dedicated H&S code for reimbursement, moving away from a monopoly of existing technologies [37] GLP-1 Impact - The introduction of GLP-1 medications is seen as a positive development, potentially expanding the patient base eligible for treatment due to improved BMI and AHI metrics [38][39] Future Studies and Innovations - Nyxoah is preparing for a study on Complete Concentric Collapse (CCC) with data expected in August 2026 and potential U.S. commercialization in late 2026 or early 2027 [41][45] - The company is also exploring dual stimulation modalities involving Ansa cervicalis, with first human trials expected within six months [48][49] Financial Performance and Projections - Gross margins are expected to improve from the low 60s to the low 80s by 2027 due to new product innovations and increased volume [52] - Operating expenses will rise as the sales force expands, with a focus on maintaining R&D investment [54] Financing and Cash Runway - Recent financing efforts have provided sufficient capital to support U.S. commercialization through early 2027, allowing flexibility for future funding decisions [55][56] Closing Remarks - Nyxoah emphasizes its commitment to providing options for OSA patients and its enthusiasm for the future of its technology [58]