Financial Data and Key Metrics Changes - Revenue for Q3 2025 was EUR 2 million, a 56% increase from EUR 1.3 million in Q3 2024 [12] - Gross margin decreased to 60.5% in Q3 2025 from 62% in Q3 2024 [12] - Total operating loss increased to EUR 24.4 million in Q3 2025 from EUR 15 million in Q3 2024, attributed to increased commercial investments in the U.S. [12] - Cash position decreased to EUR 22.5 million at September 30, 2025, down from EUR 43 million at June 30, 2025 [12] - The company secured up to $77 million in capital to support U.S. commercialization efforts [13] Business Line Data and Key Metrics Changes - The first commercial Genio implant in the U.S. generated $231,000 in revenue during Q3 2025 [5] - 15 implants were performed across nine accounts in the U.S. by the end of October 2025 [24][25] - 111 surgeons were trained on Genio, and 102 value analysis committee submissions were completed, with 35 approvals received [6][7] Market Data and Key Metrics Changes - The company is focused on expanding its U.S. commercial organization and has secured reimbursement with Medicare and 10 private payers [9][10] - The company is also driving deeper penetration in Germany and the UK, while selectively expanding into the Middle East [11] Company Strategy and Development Direction - The company aims to manage obstructive sleep apnea (OSA) as a chronic condition, integrating AI and self-learning into future Genio products [15] - The focus is on expanding the U.S. commercial organization and training more surgeons to activate more accounts [11] - The company is positioned to differentiate itself in the market by offering a bilateral stimulation solution that respects the anatomy of the hypoglossal nerve [18] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the U.S. launch, noting strong enthusiasm from physicians and patients for the Genio solution [4] - The company anticipates continued progress in securing coverage decisions from additional commercial payers [10] - The fourth quarter 2025 revenue is expected to be between EUR 3.4 million and EUR 3.6 million, reflecting ongoing growth in both U.S. and international markets [14] Other Important Information - The company has achieved a 100% approval rate on prior authorization submissions through its GEMIO access program [9] - The inclusion of CPT code 64568 in medical policies by major payers is expected to streamline patient access [10] Q&A Session Summary Question: Feedback from doctors and patients on choosing Genio - Physicians appreciate the optionality Genio provides and its bilateral stimulation solution, which is effective for complex airway obstructions [18] Question: Status of sales force build-out - The company is focused on high-volume AGNS sites and plans to add up to 15 territory managers quarterly to cover all 400 high-volume implant sites [19] Question: Number of implants and U.S. revenue in Q3 - A total of 15 implants were performed through the end of October, generating EUR 231,000 in revenue [24][25] Question: Guidance for U.S. versus international revenue - The company is not breaking out U.S. versus international revenue at this time, as it is still in the early phases of account activation in the U.S. [26] Question: Appeal of Genio among different demographics - Genio appeals to both male and female patients, with a focus on younger individuals who value the implant for life concept [35] Question: KPIs for future reporting - The company plans to provide updates on the number of surgeons trained and accounts that have implanted, while potentially dropping value analysis committee metrics in the future [41] Question: Pricing and average selling price (ASP) - The average selling price for implants is around $25,000, with expectations for U.S. revenue to grow from October to December [47][48] Question: Impact of U.S. rollout on gross margins - Long-term gross margins are expected to reach the 80% range, with improvements anticipated from the next-generation Genio and increased production volumes [50][52] Question: Phasing of reimbursement progress - The CPT code 64568 is expected to remain in use for the long term, providing a clear pathway for reimbursement with both Medicare and commercial payers [58][59]