Financial Data and Key Metrics Changes - Revenue for Q1 2025 was €1.1 million, a decrease from €1.2 million in Q1 2024, attributed to temporary softness in the international HD and S market and a phased launch of the Genio 2.1 patient software upgrade [15][16] - Total operating loss for Q1 2025 was €20.6 million, compared to €12.2 million in Q1 2024, driven by investments in the U.S. commercial organization in preparation for FDA approval and launch [16] - Cash position as of March 31, 2025, was €63 million, down from €85.6 million at the end of 2024 [16] Business Line Data and Key Metrics Changes - The company launched the Genio 2.1 patient software upgrade, which led to some sites deferring purchases until the upgrade was available [15] - The U.S. market strategy includes targeting high-volume hypoglossal nerve stimulation implanting centers and developing networks with sleep physicians [10][11] Market Data and Key Metrics Changes - The company is preparing for a U.S. commercial launch, with a focus on addressing the needs of patients and physicians seeking alternatives to current therapies for obstructive sleep apnea (OSA) [10][11] - Market research indicates significant demand for alternatives to existing pacemaker technologies among patients and physicians [10] Company Strategy and Development Direction - The company aims to achieve full PMA approval in the U.S. by Q2 2025, with a focus on building a world-class team for the U.S. go-to-market strategy [6][8] - The strategy includes a two-pronged approach: targeting high-volume centers and developing strong networks with sleep physicians [10][11] - The company emphasizes a patient-first approach and aims to differentiate itself through unique technology benefits and clinical outcomes [17][18] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in receiving FDA approval and highlighted the enthusiasm from the clinical community regarding the innovative OSA treatment options [19][20] - The company believes it is positioned for significant growth following FDA approval, with a well-prepared commercial team and established reimbursement pathways [19][20] Other Important Information - The company has identified an established CPT code (64568) for reimbursement, which is recognized by commercial and government payers for OSA indications [13] - The company is actively working with the American Academy of Otolaryngology and participating in the FDA's early payer feedback program to educate payers on the GENEOS system [12] Q&A Session Summary Question: What needs to be done at the U.S. inspection? - The FDA requested validation of a specific manufacturing process at the contract manufacturer, which is currently ongoing [22][25] Question: Can you clarify the physical site inspection status? - The site inspection is actively taking place and can last up to five days, after which a report will be submitted to the FDA [25][26] Question: What is the company's strategy for outreach to ENT and sleep doctors? - The company plans to highlight clinical data showing effectiveness in supine sleep position and positional OSA to differentiate its product [30][32] Question: Is there a statutory response time from the FDA for approval? - After the inspection, a final report will be submitted to the FDA PMA review committee, which will then issue an approval [36][38] Question: Any updates on the Dream Journal publication? - The publication is in the second level of review, and the company expects it to be published before summer [40] Question: What is the expected pace of OpEx spending going forward? - The company plans to defer costs and investments until FDA approval is achieved, extending the cash runway into Q2 2026 [42][44] Question: How is the commercial launch of GENEOS in Dubai progressing? - The company has successfully implanted GENEOS in Dubai and is expanding to other locations in the Middle East [48][49] Question: What is the status of the ACCESS study? - The company is making progress in enrolling patients for the ACCESS study, with a timeline to stop enrollment by summer [50][51] Question: Will the initial FDA approval have a contraindication for CCC patients? - The company does not expect CCC to be a contraindication but rather an off-label indication, allowing physician discretion [80][82]