Core Insights - CapsoVision, Inc. is participating in the Benchmark 14th Annual Discovery One-on-One Investor Conference on December 4, 2025, in New York City, with key executives attending [1][2] Company Overview - CapsoVision is a commercial-stage medical technology company focused on advanced imaging and AI-enabled solutions for gastrointestinal disease detection and diagnosis [3] - The flagship product, CapsoCam Plus®, is a wire-free, panoramic capsule endoscope that provides high-resolution visualization of the small bowel and supports cloud-based or direct video retrieval [3] - The upcoming product, CapsoCam Colon™, features enhanced AI for non-invasive colon imaging and polyp detection, with plans to expand across multiple gastrointestinal indications [3]

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]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _________________________ FORM 10-Q _________________________ (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2025 OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____________ and ____________ Commission file number 001-42705 _________________________ CAPSOVISION, ...

Exhibit 99.1 Operating expenses were $9.9 million, a $2.5 million increase from the third quarter of 2024, driven primarily by an increase in expenses associated with the development of the new CMOS under the development agreement with Canon Inc. and an increase in general and administrative expenses due to higher payroll and benefits expenses and stock-based compensation expenses associated with the executive officer departure and higher professional service expenses, including audit, legal and consulting ...

Core Insights - CapsoVision, Inc. reported a strong third quarter for 2025, with significant growth in revenue and product uptake, particularly for its CapsoCam Plus® endoscopy capsule [3][4][8] - The company is pursuing Breakthrough Device Designation from the FDA for its endoscopy capsule aimed at early-stage pancreatic cancer detection, highlighting its commitment to addressing unmet medical needs [3][8] - CapsoVision is advancing its artificial intelligence capabilities with the development of a next-generation analytics engine for capsule endoscopy, with regulatory submissions planned for late 2025 [3][8] Financial Performance - Total revenue for Q3 2025 was $3.5 million, representing a 19% increase compared to Q3 2024, driven by higher sales of CapsoCam Plus capsules [4][8] - Gross profit reached $1.9 million, a 16% increase from the previous year, with a gross margin of 54%, slightly down from 56% in Q3 2024 [4][8] - Operating expenses increased to $9.9 million, up $2.5 million from Q3 2024, primarily due to development costs and higher general and administrative expenses [5][8] Cash Position - As of September 30, 2025, cash and cash equivalents totaled $17.8 million, an increase from $9.3 million at the end of 2024 [6][13] - The company completed an initial public offering in July 2025, generating net proceeds of $23.4 million after expenses [6][8] Product Development and Market Engagement - New accounts grew by 31% in Q3 2025 compared to the same quarter in 2024, indicating strong market engagement [8] - CapsoVision is collaborating with Canon Inc. to develop higher-resolution CMOS image sensors for future capsule endoscopes [3][8] - The company has initiated a clinical study for its new generation colon-capsule, further expanding its product pipeline [3][8] Leadership Changes - David Garcia was appointed as Senior Vice President of Finance, effective November 3, 2025, bringing extensive experience in financial oversight [3][8]

Core Insights - CapsoVision, Inc. has submitted an application to the FDA for Breakthrough Device Designation for its CapsoCam UGI capsule endoscopy system aimed at early detection of pancreatic ductal adenocarcinoma, a highly fatal cancer [1][5] - The CapsoCam UGI system is designed to expand the company's diagnostic capabilities beyond the small bowel, addressing significant challenges in gastroenterology [2][8] - Pancreatic ductal adenocarcinoma has a low five-year survival rate of only 8%, primarily due to late-stage diagnosis, highlighting the urgent need for effective early screening tools [2][6] Company Overview - CapsoVision is a commercial-stage medical technology company focused on advanced imaging and AI-enabled solutions for gastrointestinal disease detection [8] - The flagship product, CapsoCam Plus®, is a wire-free, panoramic capsule endoscope that provides high-resolution visualization of the small bowel [8] - The company is also developing CapsoCam Colon™, which aims to enhance non-invasive colon imaging and polyp detection [8] Industry Context - Pancreatic cancer is the third leading cause of cancer-related deaths in the U.S., despite representing only about 3% of all cancer cases [6] - Approximately 80% of pancreatic cancer diagnoses occur at advanced stages, limiting treatment options [6] - Current diagnostic methods are invasive and costly, lacking the sensitivity needed for early-stage detection, which underscores the need for innovative, non-invasive technologies [6][7]

Core Insights - CapsoVision, Inc. has appointed David Garcia as Senior Vice President of Finance to support its growth phase [1][3] - Garcia brings over 20 years of financial leadership experience, including roles in corporate finance and capital markets [2] - The company aims to leverage Garcia's expertise in financial management and capital strategy to advance its development pipeline and achieve corporate milestones [3] Company Overview - CapsoVision is a commercial-stage medical technology company focused on advanced imaging and AI-enabled solutions for gastrointestinal disease detection and diagnosis [4] - The flagship product, CapsoCam Plus®, is a wire-free capsule endoscope that provides high-resolution visualization of the small bowel [4] - The upcoming product, CapsoCam Colon™, will enhance non-invasive colon imaging and polyp detection using advanced AI [4]

Core Viewpoint - CapsoVision, Inc. is set to release its third quarter 2025 financial results on November 13, 2025, and will host a conference call to discuss these results and provide a corporate update [1]. Group 1: Financial Results Announcement - The company will announce its third quarter 2025 financial results after the market closes on November 13, 2025 [1]. - A conference call and live webcast will take place on the same day at 1:30 pm PT / 4:30 pm ET to discuss the results [1]. Group 2: Company Overview - CapsoVision is a commercial-stage medical technology company focused on advanced imaging and AI-enabled solutions for gastrointestinal disease detection and diagnosis [3]. - The flagship product, CapsoCam Plus®, is a wire-free, panoramic capsule endoscope that provides high-resolution visualization of the small bowel [3]. - The upcoming product, CapsoCam Colon, features enhanced AI for non-invasive colon imaging and polyp detection [3]. - The company aims to expand its proprietary platform across multiple gastrointestinal indications, including esophageal and pancreatic disorders [3].

Core Viewpoint - CapsoVision, Inc. is actively participating in the 4th Annual ROTH Healthcare Opportunities Conference, highlighting its focus on advanced imaging and AI-enabled capsule endoscopy solutions [1] Company Overview - CapsoVision is a commercial-stage medical technology company dedicated to transforming the detection and diagnosis of gastrointestinal diseases through advanced imaging and AI solutions [3] - The flagship product, CapsoCam Plus®, is a wire-free, panoramic capsule endoscope that provides high-resolution visualization of the small bowel and supports cloud-based or direct video retrieval [3] - The upcoming product, CapsoCam Colon, features enhanced AI capabilities aimed at non-invasive colon imaging and polyp detection [3] - The company is developing a proprietary platform intended to expand across various gastrointestinal indications, including esophageal and pancreatic disorders [3]

Transforming GI Detection and Screening Our long-term, lifesaving vision is an ingestible capsule that, in a single, convenient, and noninvasive procedure, screens for multiple cancers— esophageal, gastric, pancreatic, liver, and colon—at early and still precancerous stages, using AI to analyze thousands of images captured in the GI tract. CapsoVision: Cautionary Note Regarding Forward-Looking Statements This presentation contains "forward-looking statements" that reflect our current expectations and views ...