CapsoVision, Inc. Q4 FY2025 earnings call

Johnny highlighted Capsule Vision's mission to make early, accurate, and accessible GI disease detection available. Closed 2025 with increased commercial momentum for Capsule Chem Plus. Pipeline development includes advancing AI-enabled roadmap for Capsule Chem Plus, focusing on CapsuleCAN-Gen2 for colon screening, and initiating clinical study for Capsulcan UGI program. Dave walked through commercial performance with continued expansion of Capsule Chem Plus, new account growth, and financial results with revenue growth, gross profit increase, and operating expenses rise. Strengthened balance sheet with $14 million private placement.

For Capsule Chem Plus: Full year 2025 delivered approximately 15% year-over-year revenue growth and 21% in new account generation. As of December 31, 2025, more than 161,000 patients have been imaged with Capsule Chem Plus. In the fourth quarter of 2025, approximately 9,400 patients utilized Capsule Chem Plus compared to approximately 8,374 in the prior year period, representing year-over-year growth of 12%. Total revenue for the fourth quarter of 2025 was 3.9 million, reflecting 13% growth compared to the fourth quarter of 2024. Gross profit was $2 million, an increase of $200,000, or 13%, compared to the fourth quarter of 2024. Gross margin was 50% for the quarter. For the pipeline, Capsule Can Colon Gen 2 is in development with enrollment ongoing and on track to submit 510K application in third quarter of 2026. Capsulcan UGI program is initiating a clinical study in second quarter of 2026 to establish diagnostic criteria for malignancy.

Expect to submit 510K application for CapsuleCAN-Gen2 and its AI module in third quarter of 2026. Capsule Can Colon Gen 2 expected to have FDA clearance by end of Q1 2027 and start launching in second half of 2027. Capsulcan UGI clinical study to begin in second quarter of 2026.

Q: Follow-ups on Gen 2 capsulcan colon efforts, feedback received, study results timing.

A: Gen 2 has higher resolution, image quality, field of view, and software. Enrollment going well, on track to file 510K by end of Q3.

Q: Follow-ups on breakthrough designation application for pancreatic cancer detection, diagnostic criteria, study results use.

A: Contemplating features like papilla abnormality, building score system based on study, breakthrough designation gives priority, need validation population after model establishment.

Q: Questions on colon cam development timeline, patients recruited, sites, patient accrual, review time, commercial availability.

A: Gen 2 targets 800 patients, 11 sites, close to 600 enrolled. Anticipate FDA review takes six months, expect clearance by end of Q1 2027 and launch in second half of 2027