CapsoVision, Inc. Common Stock

CapsoVision anticipates FDA clearance for its AI Highlights product by the end of the third quarter, with commercial launch expected shortly thereafter. The company reported second quarter revenue of $3.6 million, up 10% year-over-year, and gross profit of $1.9 million with a 51% gross margin. Operating expenses were $9.5 million, driven by clinical trials, engineering work, and public company costs. CapsoVision also plans to submit its CapsoCam Colon second-generation capsule and AI module for FDA review in the fourth quarter, delayed from the third quarter due to the need for more positive subjects with significant polyps. The company ended the quarter with $9.1 million in cash and established an at-the-market equity offering program of up to $100 million with Cantor Fitzgerald.

CapsoVision has launched AI Highlights for its CapsoCam Plus system to support physician review of small bowel capsule endoscopy studies. The new feature identifies frames containing suspected clinically relevant findings during standard video processing and integrates with the company's CapsoView software and CapsoCloud platform. AI Highlights is available as an update in markets where the products are authorized, including the European Union under the Medical Device Regulation, but it has not yet been approved by the U.S. Food and Drug Administration. The company's stock closed Monday at $7.17, up 8.97%.

CapsoVision has appointed gastroenterologist David S. Shields, M.D., to its Board of Directors, effective July 1, 2026. Dr. Shields brings over 40 years of experience in academic medicine, clinical gastroenterology, and advanced endoscopy, and has served as a clinical advisor to the company for nearly a decade. He succeeds Joanne C. Imperial, M.D., who will continue supporting CapsoVision as an independent clinical consultant. The appointment comes as the company approaches milestones including the anticipated commercial launch of an AI-assisted reading feature for its CapsoCam Plus capsule endoscope, continued development of its second-generation CapsoCam Colon program, and expansion of its broader capsule platform. Dr. Shields has maintained a private gastroenterology practice in Palo Alto since 1986, previously served as Assistant Professor of Medicine at Stanford University School of Medicine and Director of Endoscopy at Stanford Hospital, and has nearly two decades of experience using capsule endoscopy for small bowel disorders and gastrointestinal bleeding.