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 ...

Financial Data and Key Metrics Changes - For Q2 2025, total revenue was $3.3 million, reflecting a 17% growth compared to 2024, driven by an increase in the number of CapsoCam Plus capsules sold [23][24] - Gross margin for the quarter was 55%, consistent with expectations as the company scales [24] - Net loss was $4.6 million for Q2 2025, compared to a net loss of $5.3 million in Q2 2024 [24] Business Line Data and Key Metrics Changes - As of June 30, 2025, CapsoCam Plus for small bowel screening has been used by over 143,000 patients, with approximately 7,900 patients using the system in 2025, representing a year-over-year growth of 17% [19][20] - New accounts grew by 75% in 2025 compared to the same quarter in 2024, indicating continued physician adoption [22] - A 46% increase in GI clinics and mega GI groups was observed in 2025 over the same quarter last year [22] Market Data and Key Metrics Changes - The market potential for the CapsuleCam colon is estimated to exceed $1 billion, targeting patients at higher risk for colonoscopy-related complications [12] - The company is expanding its pipeline to address other parts of the GI tract, including pancreatic and esophageal varices screening, which represents a significant market opportunity [17][18] Company Strategy and Development Direction - The company aims to leverage its existing sales infrastructure to expand into additional indications, creating cross-sell opportunities without significant increases in headcount [22] - The development pipeline includes the submission of an AI module for CapsoCam Plus to the FDA by late September or early October, which is expected to enhance diagnostic capabilities [10][27] - The company plans to initiate pivotal studies for esophageal varices screening in 2026, further broadening its market opportunity [17] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's technology, strategy, and team to execute on growth opportunities, particularly in the small bowel market and the integration of AI [27] - The company anticipates stronger sales in Q3 and expects Q4 sales to be historically the highest due to seasonal trends [26] Other Important Information - The company completed its initial public offering on July 3, 2025, receiving total net proceeds of $23.4 million [25] - A development agreement with Canon was announced to design and evaluate next-generation CMOS image sensors, valued at approximately $4.1 million [26] Q&A Session Summary Question: Clarification on colon launch plans - The plan is for the second-generation device, not the initial device submitted [30][31] Question: Timing for the second-generation colon capsule - The submission for the second-generation device is planned for the first quarter, following the first approval [34][35] Question: Details on the Canon arrangement - The agreement includes an upfront payment of $1 million and spans a couple of years, with deliverables tied to the final engineering design [37] Question: Cash burn in the quarter and expectations for the year - Cash burn was around $11.5 million, with expectations of approximately $20 million for the year [40] Question: Timeline for AI feature submission and market receptivity - The AI module is planned for submission in September, with a launch expected next year; doctors are already aware of the feature and receptive to it [42][44] Question: Advantages of in-house AI development - The company has complete control over its AI development, which provides a significant advantage compared to relying on external partners [46]

Core Insights - CapsoVision, Inc. reported a total revenue of $3.3 million for Q2 2025, marking a 17% increase compared to Q2 2024, primarily driven by increased sales of CapsoCam Plus capsules [6][9] - The company successfully completed its IPO in July 2025, raising net proceeds of approximately $23.4 million, which will be used to accelerate growth and expand into new indications [3][7][9] - Management highlighted the importance of obtaining FDA 510(k) approval for the AI module in CapsoCam Plus and the continued development of CapsoCam Colon as key growth drivers [4][5] Financial Performance - Total revenue for Q2 2025 was $3.3 million, a 17% increase from $2.8 million in Q2 2024 [6][14] - Gross profit increased to $1.8 million, up 14% from $1.6 million in Q2 2024, with a gross margin of 55% [6][14] - Operating expenses decreased to $6.5 million, down $0.4 million from Q2 2024, mainly due to reduced expenses related to clinical trials [7][14] Operational Highlights - New accounts grew by 75% in Q2 2025 compared to the same quarter in 2024 [9] - CapsoCam Plus has been utilized by over 143,000 patients as of June 30, 2025 [9] - The company submitted a 510(k) notification to the FDA for CapsoCam Colon in June 2025 [9] Future Outlook - The company aims to enhance accuracy and ease physician workload through the integration of AI in its products [4] - CapsoVision plans to advance programs targeting pancreatic cancer and esophageal varices, leveraging its panoramic imaging technology [4][5]

Company Overview - CapsoVision, Inc. is a commercial-stage medical technology company focused on advanced imaging and AI technologies for capsule endoscopy solutions [4] - The flagship product, CapsoCam Plus, is a wire-free, panoramic capsule endoscope that provides high-resolution visualization of the small bowel [4] - The upcoming product, CapsoCam Colon, aims to enable non-invasive colon imaging and polyp detection [4] Financial Results Announcement - CapsoVision will release its second quarter 2025 financial results on August 14, 2025, after market close [1] - A conference call and live webcast will be held on the same day at 1:30 pm PT / 4:30 pm ET to discuss the results and provide a corporate update [1] Conference Call Details - Interested individuals can listen to the conference call by dialing (800) 715-9871 for domestic callers or (646) 307-1963 for international callers, referencing conference ID 1668374 [2] - The webcast will be available in the investor relations section of the company's website for one year following the call [3]

Core Viewpoint - CapsoVision, Inc. has launched its IPO at a price of $5.00 per share, aiming to raise approximately $27.5 million, marking a significant step towards enhancing its position in the global medical market focused on gastrointestinal diagnostics [1] Market and Competitive Environment - The global capsule endoscopy market is projected to reach $1.2 billion by 2030, driven by aging populations, rising prevalence of gastrointestinal diseases, and a growing preference for non-invasive examination methods [3] - CapsoVision faces intense competition, with Medtronic's PillCam holding approximately 85-90% market share, supported by a well-established product line and extensive clinical validation [3][5] - Other active competitors include Olympus, IntroMedic, and Jinshan Science & Technology, each with their own market presence and product offerings [3] Technology Pathway - CapsoVision's flagship product, CapsoCam Plus, features four high-resolution cameras arranged horizontally to create a 360-degree panoramic image of the small intestine, enhancing visibility and comfort for patients [10][12] - The Smart Motion Sense™ technology allows the capsule to adjust its frame rate based on its movement within the gastrointestinal tract, achieving a battery life of up to 15 hours [12] - Clinical studies indicate that CapsoCam Plus significantly improves visualization rates and detection of small lesions compared to traditional forward-viewing capsules [12] Product as a Platform - CapsoVision is developing a comprehensive platform that integrates image acquisition, data transmission, cloud processing, and AI analysis, exemplified by the CapsoAccess system and CapsoView software [13][15] - The CapsoCloud platform allows for remote data management, aligning with the increasing demand for telemedicine solutions, especially highlighted during the pandemic [15] - CapsoCam Plus received FDA permanent approval for remote home examinations, facilitating high-quality imaging without the need for hospital visits [15] Future Developments - CapsoVision is working on the CapsoCam Colon product, aimed at providing panoramic imaging for the colon, addressing the challenges of traditional colonoscopy [16][17] - The U.S. colon capsule endoscopy market is expected to grow to $311 million by 2030, presenting a significant opportunity for CapsoVision if it can overcome existing technical challenges [17] - The company plans to expand its technology to other gastrointestinal areas, including esophageal and pancreatic screenings, indicating its ambition to create a modular platform [18]

Core Viewpoint - CapsoVision is planning an IPO to raise up to $30 million to enhance its position in the non-invasive gastrointestinal diagnostics market, particularly for its CapsoCam Plus product [1]. Company Overview - CapsoVision, founded in 2006 and headquartered in Saratoga, California, focuses on non-invasive gastrointestinal diagnostic technologies and has entered multiple markets including North America, Europe, and Asia-Pacific [14]. Product Introduction - The core product, CapsoCam Plus, is a swallowable capsule endoscope designed for small intestine examinations, providing non-invasive and high-quality imaging [2]. - The product received FDA 510(k) certification in 2016 and expanded its indications to include pediatric patients aged 2 and above in 2025 [2]. Product Features - CapsoCam Plus features 360° panoramic imaging with four side cameras, significantly improving visual coverage compared to traditional forward-facing lenses [3]. - It offers wireless data storage, eliminating the need for external receiving devices, and allows for natural expulsion through bowel movements [3]. - The high-resolution images support the identification of common small intestine lesions such as ulcers and bleeding [3]. - The examination process does not require anesthesia or hospitalization, making it suitable for patients who are reluctant to undergo traditional endoscopy, especially children and the elderly [3]. Market Demand - The incidence of gastrointestinal diseases is rising globally, with approximately 20 million new cancer cases reported in 2023, including colorectal and gastric cancers [8]. - The global capsule endoscopy market was valued at approximately $537 million in 2023 and is projected to grow to between $1.02 billion and $1.6 billion by 2030, with a CAGR of 8.4%-9.6% [8]. - The Asia-Pacific region, particularly China, is the fastest-growing market, expected to achieve over 15% CAGR by 2030, with a market size potentially exceeding 3 billion RMB [8]. Competitive Landscape - The capsule endoscopy market is highly concentrated, with Medtronic leading globally, while local companies like AnHuan and Jinshan are rapidly emerging in the Chinese market [9][11]. - CapsoVision's CapsoCam Plus competes with products from Medtronic, IntroMedic, and Olympus, each offering unique features such as AI integration and remote access capabilities [9][11]. Software and Technology - The CapsoView software, launched in 2023, supports cloud-based access and data sharing, enhancing image analysis efficiency [7][10]. - The company is exploring the integration of artificial intelligence to improve diagnostic accuracy and efficiency [7][10].