5/14/2026

speaker
Operator
Operator

Hello, and thank you so much for standing by. Ladies and gentlemen, welcome to CAPSO Vision Q1 2026 Earnings Conference Call. Please note that this call is being recorded at this time. All participants are in listen mode only. There will be some opening remarks followed by question and answer session. If you wish to ask a question, please press star one on your telephone keypad. Thank you.

speaker
Capital Vision Investor Relations
Moderator

Thank you, operator. Good afternoon, everyone, and thank you for joining us for Capital Vision's first quarter 2026 earnings call. Joining me today are Donnie Wang, President and Chief Executive Officer, and Senior Vice President of Finance, David Garcia, as well as Doug Atkinson, Senior Vice President of Sales. 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 most recent Form 10-Q filed by us 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 change in 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 Capsovision'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 for Johnny, David, and Doug to take your questions. With that, I'll turn the call over to Johnny Wine. Johnny?

speaker
Donnie Wang
President and Chief Executive Officer

Thank you, Li, and good afternoon, everyone. Capsule imaging remains focused on advancing earlier, more accurate, and more accessible detection of gastrointestinal disease for patients worldwide. We are working toward a unified, ingestible capsule platform capable of screening for multiple cancers, including esophageal, gastric, pancreatic, liver, and colorectal through a single non-invasive procedure enabled by advanced imaging and AI. With that as our foundation, we continued to see consistent, solid underlying performance in the first quarter. While revenue and new account additions remained stable year over year, we saw further expansion of CapsuleCAM used to detect a widening range of small bowel diseases. In the first quarter, underlying procedural volume reflecting end-user consumption continued to expand, demonstrating deeper engagement with existing accounts and increasing reliance on Capsule Chem Plus in routine clinical practice. We believe this trends reinforce the strengths of our installed base and highlights the growing role our platform is playing in supporting physician workflow and patient care. During the quarter, we also secured key renewals for large GI networks, including Indiana University Health Systems, Providence Health Systems, and GastroHealth. which we believe reinforces the value of our platform and the strength of our long-term customer relationships. Turning to our technology platform, we are entering an important phase in our AI strategy. As you know, we previously submitted our 510K application for our AI-assisted reading capability for KepsoCam+. We continue to expect a clearance around mid-year, and we are preparing for a commercial launch shortly thereafter. We have been actively demonstrating this capability, which we have branded AI highlights at the recent industry meetings, and the feedback from gastroenterologists has been very encouraging. Physicians are particularly focused on the potential to streamline review time while maintaining clinical rigor, which we believe will be an important driver of adoption. AI Highlights is designed to identify frames with suspected pathology and present them within a structured review workflow fully integrated within our cloud-native Capsule Cloud platform. We believe this capability has the potential to reduce the physician waiting time while enhancing workflow efficiency and represents a meaningful step forward in advancing a fully integrated AI-enabled diagnostic system. Building on that momentum, we continue to make steady progress across our pipeline. For CapsuleCAN, our development program remains on track. With the merging of our second generation capsule and its AI module expected in the third quarter of 2026, we continue to believe that our decision to prioritize Gen2 positions us to enter the market with a more competitive and clinically differentiated product. Turning to our Capsule Chem UGI program, and the pancreatic cancer initiative. We are pleased to report that enrollment began this week in our clinical study. This represents an important milestone as we work to establish diagnostic criteria and to build the clinical foundation for what we believe could be a first of its kind non-invasive screening approach for pancreatic disease. While this remains a longer-term opportunity, we continue to believe the potential impact in this area is significant, given the lack of effective early detection tools today. Overall, we believe the business is progressing as expected. We are seeing continued strength in utilization, advancing key pipeline programs, and moving closer to what we expect will be an important inflection point with the introduction of AI-enabled capabilities. More broadly, we remain focused on redefining how gastrointestinal diseases are detected, leveraging our platform to make diagnosis earlier more accessible and more efficient for both patients and providers. With that, I will turn the call over to Dave to walk through our commercial and financial results.

Disclaimer

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Q1CV 2026

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