CapsoVision Q1 Earnings Call Highlights
CapsoVision (NASDAQ:CV) reported steady first-quarter revenue and said it continues to advance artificial intelligence and capsule endoscopy programs aimed at expanding the use of its gastrointestinal imaging platform.
On the company’s first-quarter 2026 earnings call, President and Chief Executive Officer Johnny Wang said CapsoVision remains focused on developing “a unified ingestible capsule platform” intended to screen for multiple cancers through a single non-invasive procedure supported by advanced imaging and AI.
“We continued to see consistent solid underlying performance in the first quarter,” Wang said. “While revenue and the new account additions remained stable year-over-year, we saw further expansion of CapsoCam used to detect a widening range of small bowel diseases.”
Revenue Holds Steady as Shipments Dip Slightly
Senior Vice President of Finance David Garcia said first-quarter revenue was $2.8 million, consistent with the prior-year period. CapsoVision shipped 6,229 CapsoCam Plus capsules during the quarter, down 3% from 6,447 capsules in the prior-year period.
Garcia attributed the decline in capsule shipments to timing, saying some larger orders moved into April and were therefore placed in the second quarter. He said the lower unit volume was offset by a slight increase in average selling price, which reflected a mix shift toward higher-priced regions rather than a price increase.
As of March 31, Garcia said more than 167,000 patients had been imaged with CapsoCam Plus for small bowel screening across U.S. and international markets. He also said reimbursement under CPT Code 91110 continues to support adoption across private practices and hospital systems.
Gross profit for the quarter was $1.3 million, with gross margin of 48%, compared with 54% in the first quarter of 2025. Garcia said the margin decline was primarily due to tariffs affecting cost of goods sold.
Operating expenses were $8.4 million, up $1.5 million from the prior-year period. The increase was primarily driven by continued investment in the company’s pipeline, including development work tied to a next-generation imaging sensor under its agreement with Canon and clinical trial activity for the CapsoCam Colon Gen Two program.
CapsoVision ended the quarter with $17.9 million in cash and cash equivalents. Garcia noted that the company closed a $14 million private placement in March with participation from new and existing investors, which he said provides added flexibility to support product innovation, clinical development and commercial expansion.
AI Highlights Clearance Expected Around Mid-Year
Wang said CapsoVision continues to expect regulatory clearance around mid-year for its AI-assisted reading capability for CapsoCam Plus, which the company has branded AI Highlights. The company previously submitted a 510(k) application for the feature and is preparing for a commercial launch shortly after clearance.
AI Highlights is designed to identify frames with suspected pathology and present them in a structured review workflow integrated into CapsoVision’s cloud-native CapsoCloud platform. Wang said physicians have responded positively to demonstrations of the technology at recent industry meetings, particularly its potential to reduce review time while maintaining clinical rigor.
During the question-and-answer portion of the call, Titan Partners analyst Kyle Bauser asked about the status of the FDA application. Wang said the company and the FDA had several interactions in recent months, and that CapsoVision had responded to the agency’s requests.
“We are waiting for a meeting in the next few weeks,” Wang said. “We have no showstoppers to my knowledge.”
Pipeline Programs Continue to Advance
CapsoVision said its CapsoCam Colon development program remains on track, with submission of its second-generation capsule and AI module expected in the third quarter of 2026. Wang said the company believes prioritizing the second-generation product positions it to enter the market with a more competitive and clinically differentiated offering.
The company also reported progress in its CapsoCam UGI program and pancreatic cancer initiative. Wang said enrollment began this week in a clinical study intended to establish diagnostic criteria and build a clinical foundation for a potential non-invasive screening approach for pancreatic disease.
In response to a question from Bauser, Wang said the study is planned to enroll 120 patients with confirmed high-grade dysplasia or pancreatic cancer, with a target enrollment of 140 to account for possible dropouts. The study will also include 120 healthy reference subjects, with those images pulled from the company’s cloud storage repository, for a total of 240 subjects.
Wang declined to provide a specific enrollment timeline but said he viewed the pancreatic study as “a much shorter study than colon.”
Commercial Base and Outlook
CapsoVision said it secured renewals during the quarter with several large gastrointestinal networks, including Indiana University Health, Providence Health Services and Gastro Health. Wang said those renewals reinforce the value of the company’s platform and its long-term customer relationships.
Garcia said CapsoVision continues to see engagement from larger gastroenterology networks, hospital systems and group purchasing organizations, particularly as contracts come up for renewal and providers evaluate alternatives. As of quarter end, the company’s U.S. direct sales organization included 26 representatives, supported by seven regional sales managers and trainers. Internationally, CapsoVision has a dedicated team of four representatives in Germany and continues to expand through distributor partnerships.
Garcia said the company expects second-quarter revenue to be higher than first-quarter revenue and expects revenue in the second half of the year to exceed first-half revenue. He cited pipeline momentum, customer engagement and the anticipated launch of the AI module for CapsoCam Plus.
Asked about operating expenses, Garcia said investment in the colon study is expected to continue through the third quarter and begin trailing off in the fourth quarter, when the company expects the colon study to be completed. He said remaining expenses should be fairly stable, with nominal growth to support the business. Garcia also said full-year research and development spending is expected to be similar to 2025.
Wang emphasized that the company’s cloud-based workflow gives CapsoVision visibility into end-user consumption and utilization. “We can tell you the end user consumption growth is healthy,” he said.
Wang said CapsoVision remains focused on advancing an AI-enabled platform built around panoramic imaging, cloud-native workflow and AI-assisted diagnostics. He said the platform allows physicians to securely review cases “anytime and anywhere” without on-site servers or dedicated IT infrastructure, while also creating a cloud-based data repository that could support continued AI development and training over time.
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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