Aug 13, 2026 earnings call — International launch of AI Highlights and FDA timing
Reported Q2 revenue of $3.6 million, an increase of approximately 10% year-over-year.
Revenue $0.0B (est $0.0B) · EPS $-0.15 (est $-0.13)
Key quotes
"One of the most significant accomplishments during the quarter was the commercial launch of AI Highlights in the European Union and other international markets."
"During the quarter, we also continued to secure important customer renewals, including University of Minnesota Medical Center, Henry Ford Medical Center, the University of Colorado Medical Center and Providence Swedish Medical Center, making CapsoCam the #1 capsule used in hospitals in the state of Washington."
"So CapsoCam Colon, development continues to advance well, and we now expect to submit our second-generation capsule and AI module for FDA review during the fourth quarter of this year."
Analyst Q&A 2
Why prices fell and who pays tariffs
Q (Bruce Jackson · StoneX): He asked whether the pricing pressure came from competitors or hospitals being cost conscious, and whether the tariff impact was on inbound raw materials or outbound sales.
A: Management said the pricing pressure came from one particular competitor and that tariffs were on inbound costs. They also said Q4 is the strongest quarter and the second half is stronger than the first. Management added they plan to increase system value by launching AI in the U.S. to help keep price and margin.
"And then the second part of your question about the tariffs, that's inbound." — David Garcia
AI rollout, colon submission, and salesforce plans
Q (Kyle Bauser · Titan Partners): He asked for early feedback on AI Highlights launched in the EU and how helpful it is for U.S. launch. He also asked what remains before the CapsoCam Colon submission by Q4 and whether the current sales team size is adequate going forward.
A: Management said launching AI internationally (primarily in the EU) is meant to build real-world experience on CapsoCloud and CapsoView and to make physicians more efficient, which should drive adoption and help the U.S. launch in Q4. They said demographic analysis is a key item to address for FDA clearance and that no one can guarantee approval. On the salesforce, they plan to grow over time but can use the current reps and management now and will expand where it makes sense.
"Looking at AI as a whole, it's a primary and important driver of adoption of capsule endoscopy." — Douglas Atkinson