Financial Data and Key Metrics Changes - Revenue for Q2 2025 was €1,300,000, an increase of 73.8% compared to €800,000 in Q2 2024 [16] - Gross margin for Q2 2025 was 63.4%, essentially flat compared to the previous year [16] - Total operating loss for Q2 2025 was $19,900,000, up from $13,300,000 in Q2 2024, driven by increased commercial investments in the U.S. [16][17] - Cash position as of June 30, 2025, was €43,000,000, down from €63,000,000 at March 31, 2025 [17] Business Line Data and Key Metrics Changes - The GENIOR system received FDA PMA approval, marking a significant advancement in treatment options for obstructive sleep apnea (OSA) patients in the U.S. [5][6] - The device demonstrated a compliance rate of 85.9% and a patient satisfaction score of 90% [10] Market Data and Key Metrics Changes - The U.S. market for OSA treatment is concentrated, with approximately 1,400 implanting accounts, of which 350 to 400 are high-volume accounts representing 75% to 80% of total revenue [34][35] - The company has identified demand from patients hesitant about receiving implanted batteries, which the GENIOR system addresses with its unique design [13] Company Strategy and Development Direction - The company has a two-pronged launch strategy targeting high-volume hypoglossal neurostimulation implanting centers and developing strong referral networks with physicians managing large populations of OSA patients [11][36] - The company aims to differentiate itself through its unique technology benefits and patient focus, particularly in the context of competition with GLP-1 treatments [14][15] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the success of the U.S. launch, citing enthusiastic responses from physicians and patients [19] - The remainder of 2025 is expected to be transformative as the company establishes GENIOR in the U.S. market [20] Other Important Information - The company has stopped enrollment in the ACCESS study, believing that the current number of patients enrolled is sufficient for meaningful conclusions [8] - A patent lawsuit initiated by Inspire Medical against the company will not impact the U.S. commercial launch [15] Q&A Session Summary Question: Year-end 2025 metrics and indicators to focus on - Management will track the number of trained physicians and value analysis committee applications as leading indicators [22][24] Question: Leveraging the differentiated label - The company plans to capitalize on the label differentiation by emphasizing the ability to treat positional OSA and the lack of contraindication for complete concentric collapse (CCC) patients [26][28] Question: Commercial strategy and targeted accounts - The sales team will focus on high-volume implanting accounts, which represent a significant portion of revenue [34][35] Question: Reimbursement strategy and payer onboarding - The company expects to see pre-authorization decisions coming in this year, while coverage decisions may be more of a 2026 story [41][42] Question: Access trial and CCC patient treatment - The company will not promote off-label indications but is optimistic about treating CCC patients once the ACCESS trial data is available [69][71] Question: Pricing strategy - The company intends to follow the same pricing strategy as competitors, pricing at approximately $25,000 [74] Question: Initial surgeon engagement and market share - Surgeons must present five defined patient cases before being trained, and the company does not set specific market share expectations at this stage [77][79]