CapsoVision, Inc.

Good afternoon and welcome to CapsuleVision's third quarter 2025 earnings conference call. All participants are in a listen-only mode. After the presentation, we will have a question and answer session. So if you'd like to ask a question, please press star and the number one on your telephone keypad. Otherwise, if you'd like to withdraw your question or your question has been answered, please press star one again. Thank you. I will now turn the call over to Lee Salvo. Investor Relations for Capsovision. Please go ahead.

Thank you, Operator. Good afternoon, everyone, and thank you for joining us for Capsovision's third quarter 2025 earnings call. Joining me today are Johnny 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 Capital 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, David, and Doug to take your questions. With that, I'd like to turn the call over to Johnny Wang, CEO. Johnny?

Thank you, Lee, and good afternoon, everyone. ExoVision's vision has always been clear to make early, accurate, and accessible VI disease detection available to patients everywhere. Our long-term vision remains to deliver an ingestible capsule drug cream for multiple cancers, FWGO, gastric, pancreatic, liver, and colorectal in a single non-invasive procedure powered by advanced imaging and AI. We delivered a strong third quarter, highlighted by 19% year-over-year revenue growth, a 31% increase in new account generation, and the milestone of more than 151,000 patients having used our capital can plus system to date. This result reflects the growing market adoption and the strong physician engagement as more clinics embrace the advantages of our wire-free panoramic TEMPTL technology. TEMPTL 10 Plus provides a complete 360-degree view of the small bowel with a 97% completion rate, giving physicians the clarity and the efficiency may need for accurate diagnosis. Combined with our secure cloud-based workflow, providers can review cases anytime and anywhere without the presence of servers or hardware. That same cloud infrastructure continues to build a vast de-identified image database that fuels our proprietary AI development. On the pipeline development front, we have continued to make exciting progress that I'd like to share. First up, we continue to invest in AI to improve our existing products and the major significant progress with the clinical study to demonstrate the benefits of incorporation of our AI technology into capsule chem class. We currently plan to submit the related fighting case application to the FDA by year end of 2025. This updated timing represents a slight delay from our previously anticipated timing due to resource constraints on our third-party biostatistic station. To mitigate further delays, we have contracted with an additional biostatistical consulting group. We expect that it will take approximately six months for the FDA to review our application, and the pending clearance commercialization is planned to begin shortly thereafter. Capital Vision is, to our knowledge, the only capital endoscopy company with a true in-house AI core competency. The scale and the quantity of our growing image data shows inherent in our cloud-based architecture creates a powerful foundation for training AI models and uncovering new clinical insights that will continue to set our platforms apart. And because our system is fully cloud-based, it eliminates the need for on-site servers reduces costs and downtime, and removes the IT burden for clinicians. The result is a CI-enabled diagnostic platform designed to deliver efficiency, accuracy, and accessibility to GI practices across all settings. We also made important progress extending our pipeline with the recent submission of an application for breakthrough device designation to pursue use of our non-invasive capsoendoscopy system to enable earlier detection of pancreatic ducted adenocarcinoma. A major milestone in our mission to bring screening to one of the deadliest cancers worldwide. And it represents an important step in capso vision Leading to expand our cancer-based diagnostic platform beyond small bowel and address some of the most challenging diseases in gastroenterology. Pancreatic duct ethyl carcinoma, the most common form of pancreatic cancer, has a five-year survival rate of only 8%, largely because it is diagnosed as advanced stages that cannot be treated. Currently, no early screening tools are recommended to identify the disease at a treatable stage. CAPSTOL regions pursue the prevention use of CAPSTOL-10 UGI endoscopy to identify pancreatic disease at an early stage. The device's unique panoramic imaging capability enables clear visualization of the uterine papilla, a small ball landmark that controls the release of digestive fluids from pancreas. Changes in the papilla's appearance can be associated with pancreatic abnormalities and may serve as early indicators of disease. Unlike traditional endoscopic or imaging procedures, Hepstocan UGI is completely non-invasive. Patients similarly swallow a pure-sized camera. eliminating the need for sedation, intubation, or recovery time, while enabling physicians to review detailed images through a secure cloud-based system. The SDS Breakthrough Devices Program is designed to expedite the development and review of technologies that may offer more effective diagnosis or treatment for life-threatening conditions where no adequate alternative exists. If granted, the designation would allow capsaicin regions to work closely with the FDA to accelerate development and share upcoming clinical studies for the regulatory new process. We are also advancing our capsaicin choline program Our Gen 1 510K submission is currently under FDA review, and we have begun enrolling patients in our pivotal study for the Gen 2 capsule. This version incorporates enhanced optics and AI for improved accuracy, and it's on track for submission in the second quarter of 2026, with potential clearance in the fourth quarter of 2026. We are also very pleased to be partnering with Canon Incorporated on next generation imaging technology. Earlier in the third quarter, we entered into a development agreement focused on creating advanced CMOS imaging sensors with higher resolution and a dynamic range. These sensors are designed to further enhance image quality and performance. in future versions of our capital endoscopes, supporting our goal to deliver the most precise and reliable visualization in the industry. Finally, we continue to build our organization for growth. Following our successful IPO earlier this year, we were pleased to welcome Mr. David Garcia as Senior Vice President of Finance. His deep financial leadership and the capital markets experience will be instrumental as we move into the next stage of execution and growth. Overall, Q3 is a strong quarter across the board, commercially, operationally, and strategically. All progress in AI are the advising pipeline for early detection of major cancers, and the continued expansion of capital can plus adoption of reaffirms our competence in leading the next generation of non-invasive AI-enabled GI screening and diagnostics. I will now turn the call over to Dave to cover recent commercial and operational highlights, as well as our financial results for the third quarter. Dave?