CapsoVision NASDAQ: CV reported second-quarter revenue growth as sales of its CapsoCam Plus capsule endoscopy system increased, while the company advanced its artificial intelligence software rollout and development programs for colon and upper gastrointestinal applications.
Revenue for the second quarter of 2026 was $3.6 million, up approximately 10% from $3.3 million in the same period a year earlier. Senior Vice President of Finance David Garcia said the increase reflected a 13% year-over-year rise in CapsoCam Plus capsule sales, partly offset by an approximately 3% decline in average selling prices.
The company shipped 8,845 CapsoCam Plus capsules during the quarter, compared with 7,856 in the prior-year period. More than 176,000 patients worldwide had been imaged using CapsoCam Plus as of June 30, up 23% from more than 143,000 patients at the end of the second quarter of 2025, according to management.
Commercial adoption and customer renewals
President and Chief Executive Officer Johnny Wang said CapsoVision continued to expand adoption among larger hospital systems and gastroenterology networks, renew customer relationships and add new accounts during the quarter. He also cited utilization growth across the company’s installed base.
Garcia said the quarter’s growth came from both continued use by existing customers and new account traction. The company renewed relationships with M Health Fairview University of Minnesota Medical Center, Henry Ford Hospital, the University of Colorado Anschutz Medical Campus and Providence Swedish.
Garcia said Providence Swedish made CapsoCam the most-used capsule in hospitals in Washington state. CapsoVision had 26 U.S. direct sales representatives at quarter-end, supported by seven regional sales managers and trainers. Internationally, it sells through a combination of direct operations and distributors, including a dedicated commercial organization in Germany.
Senior Vice President of Global Sales Doug Atkinson said the company expects to expand its sales force and add territories where appropriate, while using the existing organization to support both its small-bowel diagnostic business and potential future colon products.
AI Highlights launches internationally
A key second-quarter development was the commercial launch of AI Highlights in the European Union and other international markets. The software is intended to identify frames containing suspected pathology and present them in a structured physician workflow.
The capability is integrated with CapsoVision’s CapsoView software and CapsoCloud platform. Wang said the company views the combination of panoramic capsule imaging, AI-assisted analysis and cloud-based workflow as a competitive differentiator rather than offering AI as a standalone feature.
CapsoView software with AI analysis tools and CapsoCloud are included in the scope of CapsoVision’s European Union quality management system certificate under the Medical Device Regulation. Both are classified as Class IIa medical devices in Europe, management said.
Atkinson said AI could help physicians reduce the time required to review capsule endoscopy studies and potentially allow them to perform more procedures. He said the international rollout will give the company real-world experience with the platform ahead of its planned U.S. introduction.
CapsoVision submitted a 510(k) application for AI Highlights to the Food and Drug Administration in December 2025. Wang said the FDA requested additional information regarding demographic representation in the clinical data supporting the filing. The company expects FDA clearance by the end of the third quarter, followed by a commercial launch shortly thereafter, though Wang noted that FDA clearance cannot be guaranteed.
Pipeline progress and financial results
CapsoVision said it now expects to submit its second-generation CapsoCam Colon capsule and AI module for FDA review during the fourth quarter. The timing shifted by one quarter because the company needs more positive subjects with significant polyps, based on discussions with the FDA.
The company also said enrollment is continuing as planned in its CapsoCam UGI clinical study evaluating pancreatic cancer detection. Wang described the program as an early-stage clinical development effort and a potential long-term opportunity for the company’s capsule platform.
Second-quarter gross profit was $1.9 million, compared with $1.8 million in the year-earlier quarter. Gross margin declined to 51% from 55%. Garcia attributed the margin pressure primarily to competitive pricing and higher customs and tariff expenses tied to changes in U.S. trade policies. During the question-and-answer session, he said the tariff impact was related to inbound costs, while competitive pressure came in part from a particular competitor.
Operating expenses rose to $9.5 million from $6.5 million a year earlier. The increase included investments in product and clinical development, expenses related to the colon pivotal study and other clinical trials, non-recurring engineering work for the colon program, public-company costs and stock-based compensation.
CapsoVision ended the quarter with $9.1 million in cash and cash equivalents. Garcia noted that the company raised $14 million in gross proceeds through a private placement in the first quarter and recently established an at-the-market equity offering program of up to $100 million with Cantor Fitzgerald.
Looking ahead, management said it expects second-half revenue to exceed first-half revenue, with the fourth quarter typically representing the strongest period of the year due to seasonality. The company expects commercial momentum to be supported by wider CapsoCam Plus adoption, engagement with larger hospital and GI networks, international availability of AI Highlights and the anticipated U.S. AI software launch following FDA clearance.
About CapsoVision (NASDAQ:CV)
CapsoVision, Inc NASDAQ: CV is a medical device company specializing in advanced capsule endoscopy systems for gastrointestinal diagnostics. The company’s flagship product, the CapsoCam® Plus System, features a swallowable, tether-free capsule equipped with four side-viewing cameras that capture high-resolution, 360-degree images of the small intestine. By storing images internally rather than transmitting data wirelessly, CapsoCam Plus enables patients to maintain normal daily activities during the procedure and reduces the risk of signal loss or image drop-out.
In addition to its capsule hardware, CapsoVision offers CapsoCloud®, a secure, cloud-based platform that streamlines image retrieval, storage and reporting.
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