CapsoVision, Inc.

Ladies and gentlemen, thank you for standing by. At this time, I would like to welcome everyone to the Capsule Vision fourth quarter 2025 earnings conference call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press star, followed by the number one on your telephone keypad. If you would like to withdraw your question, again, press the star one. I would now like to turn the conference over to Lei Salvo, Investor Relations. You may begin.

Thank you, Operator. Good afternoon, everyone, and thank you for joining us for Capsovision's fourth quarter and full year 2025 earnings call. Joining me today are Johnny Wang, President and Chief Executive Officer, and David Garcia, Senior Vice President of Finance, as well as Doug Atkinson, Senior Vice President of Sales, who will be joining us for the Q&A session. Before we begin, please remember that today's remarks include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Actual events or results could differ materially due to a number of risks and uncertainties, including those mentioned in the Form 10-K filed today with the SEC. These forward-looking statements speak only as of the date of this call, and we expressly disclaim any obligation or undertaking to disseminate any updates or revisions to any forward-looking statement contained herein to reflect any changing our expectations with regard thereto or any change in events, conditions, or circumstances on which any such statement is based. Our call today will cover the following agenda. Johnny will begin with an update on Capco Vision's business, target markets, and recent highlights from our pipeline development. Then Dave will walk through a commercial update and recent financial results. After our prepared remarks, we'll open the call up for Johnny, Dave, and Doug to take your questions. With that, I'd like to turn the call over to Johnny.

Thank you, Lee, and good afternoon, everyone. Capsule vision's mission remains clear to make early, accurate, and accessible GI disease detection available to patients everywhere. Our long-term vision is to deliver an ingestible capsule capable of screening for multiple cancers, including esophageal, gastric, pancreatic, liver, and the colon rectal, in a single non-invasive procedure, powered by advanced imaging and AI. With that as our foundation, we closed 2025 with increased commercial momentum for Capsule Chem Plus, a small-ball capsule endoscopy solution. For the full year, we delivered the approximately 15% year-over-year revenue growth and 21% in new account generation, reflecting continued adoption of Capsule Chem Plus. Across both new and existing customers, as of December 31, 2025, more than 161,000 patients have been imaged with Capsule Chem Plus. We believe this growing installed base, combined with strong physician engagement, reinforces the value of our depreciated platforms. A wire-free capsule with unparalleled features, including 360-degree panoramic imaging on both storage and a fully cloud-based workflow that eliminates the need for external hardware worn on patients' body or on side computing infrastructures. Importantly, cloud-based architecture is not just a workflow advantage. It also serves as the foundation of our AI strategy. Our expanding image repository of the cloud storage continues to strengthen our ability to develop and deploy AI models that improve diagnostic accuracy, reducing reading time, and enhance clinical efficiency. On the pipeline development front, we have continued to make exciting advances that I'd like to share. Starting with Capsule Chem Plus, we are advancing our AI-enabled roadmap. At the end of last year, we submitted our 510K application for our AI-assisted reading module, which is designed to enhance lesion detection and streamline physician review. We believe this represents an important step in further differentiating our core platform and expanding its clinical and economic value. Building on that momentum, we continue to advance our Capsule Can Call-in program. Following constructive engagement with the FDA, we have refined our development strategy to prioritize our second-generation capsule. The Gen1s are medium, and subsequent FDA interactions provided valuable insights into both the regulatory pathway and evolving product expectations. Based on that feedback, we see a clear opportunity to advance directly to a more capable system that incorporates improved imaging performance, expanded field of view, and enhanced AI functionality. As a result, we are focusing on our resources and authorizing the development of CapsuleCAN-Gen2, which we believe will deliver a more competitive and clinically differentiated solution at launch. We view this as a disciplined and value-driven approach, enabling us to bring a stronger product to market from the outset, rather than iterating possible clearance. We have already enrolled over 500 patients in our pivotal study and are extending enrollment across the U.S. sites. We now expect to submit our 510K application for capsulcan colon Gen 2 and its AI module in the third quarter of 2026. Turning next to our capsulcan UGI program and the pancreatic cancer initiative, we continue to see significant long-term potential for a non-invasive screening approach in one of the most challenging areas in medicine. We believe we are pioneering a novel visual assessment method for the detection of pancreatic cancer, building our platform's ability to evaluate abnormalities of the duodenal wall and to clearly identify key anatomical landmarks, such as the papilla of water. This approach is grounded in both our prior clinical work and established scientific literature and represents a potential paradigm shift in how pancreatic disease could be detected at an earlier, more treatable stage. Following our initial breakthrough device designation submission, we engaged with the FDA and received constructive feedback which confirmed the system's ability to visualize the papilla and associated abnormalities. The feedback also outlined the need to further define diagnostic criteria, which we view as a natural next step in developing a first-of-its-kind screening modality. To address this, we are initiating a clinical study expected to begin in the second quarter of 2026. This study will enroll approximately 619 patients, and it's designed to establish diagnostic criteria for malignancy using the Capsulcan UGI system. We are conducting this work in collaboration with clinical experts, key opinion leaders, including leadership of the top professional societies in the pancreatobiliary fields. We believe this study will be an important step in generating the data needed to support both regulatory advancement and future breakthrough designation resubmission, while continuing to build the clinical foundation for a non-invasive approach to early pancreatic cancer detection. Importantly, our regulatory pathway for Capital 10 UGI is independent of the breakthrough program and will remain on track in advancing this initiative. Finally, and supporting all these efforts, we recently strengthened our balance sheet with the completion of a $14 million private placement with participation from both new and existing inventors. We believe this reflects continued confidence in our strategy and provides additional flexibility to invest in product innovation, clinical development, and commercial expansion. Overall, we believe we are well positioned heading into 2026 with a growing commercial base, a differentiated AI-enabled platform, and a disciplined approach to advancing our pipeline. We remain focused on executing our strategy and delivering long-term value for patients, physicians, and shareholders. I will now turn the call to Dave to cover current commercial and operational highlights, as well as our financial results for the fourth quarter. Dave?