Financial Data and Key Metrics Changes - Total revenue for Q3 2025 was $3.5 million, reflecting a 19% increase compared to Q3 2024, driven by an increase in the number of CapsoCam Plus capsules sold [15] - Gross margin was 54% for the quarter, consistent with expectations as the company scales [15] - Net loss for Q3 2025 was $7.9 million, compared to a net loss of $5.8 million in Q3 2024 [16] - Cash and equivalents at the end of the quarter were $17.8 million, an increase from $1.1 million at June 30, 2025, following the completion of the IPO [16] Business Line Data and Key Metrics Changes - CapsoCam Plus has been used by over 151,000 patients, with approximately 8,336 patients using the system in Q3 2025, representing a 20% year-over-year growth [11] - New account generation grew by 31% in Q3 2025 compared to the same quarter in 2024, indicating strong physician adoption [14] - A 24% increase in GI clinics and mega GI groups was noted in Q3 2025 over the same quarter last year [14] Market Data and Key Metrics Changes - The company is gaining traction in hospitals and GPOs, with a 26% increase in hospital system customers over the prior year [14] - The U.S. direct sales team included 26 representatives, supported by seven regional sales managers and trainers as of September 30, 2025 [12] Company Strategy and Development Direction - The long-term vision is to deliver an ingestible capsule that can screen for multiple cancers in a single non-invasive procedure powered by advanced imaging and AI [4] - The company is investing in AI to improve existing products and plans to submit an application to the FDA by year-end 2025 for AI technology incorporation into CapsoCam Plus [5][6] - CapsoVision is pursuing Breakthrough Device Designation for its non-invasive capsule endoscopy system to enable earlier detection of pancreatic ductal adenocarcinoma [7][8] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the momentum across the business, highlighting commercial growth, pipeline expansion, and advancements in AI-assisted diagnostics [18] - The application for Breakthrough Device Designation reflects the urgent need for early detection of pancreatic cancer and the promise of the company's technology [18] - The company is strengthening its leadership team and executing a clear growth plan following a successful IPO [19] Other Important Information - The company has a development agreement with Canon Incorporated to design next-generation CMOS imaging sensors, marking a key step in advancing its innovation pipeline [16] - R&D expenses related to the Canon agreement were $1.6 million for Q3 2025, considered a one-time charge [15] Q&A Session Summary Question: Impact of AI feature submission on other milestones - Management indicated that the FDA review typically takes three to six months, so the approval should be available in the second half of the year [22] Question: Operating expenses related to Canon agreement - The $1.6 million expense for R&D for Canon is a one-time charge, and future core R&D expenses should be lower [23] Question: Clinical data for breakthrough designation application - A small feasibility study conducted six years ago showed promising results, with two out of 20 subjects diagnosed with cancer [28] Question: Timeline for Canon CMOS sensor - The pivotal study for pancreatic cancer will proceed without waiting for the Canon sensor, which is expected to be ready in 2026 [35] Question: Commercial organization headcount - The current sales team will be maintained, with plans to add two additional territories in 2026 as needed [36]