CapsoVision (NASDAQ:CV) executives highlighted continued commercial growth for its CapsoCam Plus small-bowel capsule endoscopy product and provided updates on regulatory and clinical milestones for the company’s pipeline during its fourth-quarter and full-year 2025 earnings call.
Commercial momentum for CapsoCam Plus
Chief Executive Officer Johnny Wang said the company ended 2025 with “increased commercial momentum” for CapsoCam Plus and reiterated CapsoVision’s broader mission to improve early, accurate, and accessible gastrointestinal (GI) disease detection. Wang described the company’s long-term vision as an ingestible capsule capable of screening for multiple cancers “in a single non-invasive procedure” supported by advanced imaging and artificial intelligence.
In the fourth quarter alone, Garcia said approximately 9,400 patients utilized CapsoCam Plus, up from about 8,374 in the prior-year period, representing 12% year-over-year growth. Garcia cited increasing physician awareness, clinical utility, and ease of workflow integration as drivers. He also pointed to reimbursement support across private practices and hospital systems.
Management emphasized the product’s differentiation as a “wire-free capsule” featuring 360-degree panoramic imaging, onboard storage, and a cloud-based workflow that does not require external hardware worn on the patient’s body or on-site computing infrastructure. Wang added that the cloud architecture supports the company’s AI strategy by enabling a growing image repository for model development aimed at improving diagnostic accuracy and reducing physician reading time.
Sales execution and channel expansion
Garcia said CapsoVision’s commercial strategy includes leveraging its existing sales infrastructure as it expands into new indications, including a cross-selling opportunity for CapsoCam Colon if and when it receives FDA approval. As of year-end, the company’s U.S. direct sales organization consisted of 26 representatives supported by seven regional sales managers and trainers. Internationally, CapsoVision has a dedicated team of four representatives in Germany and is expanding through distributor partnerships in other markets.
New account growth increased 16% year over year in the fourth quarter, according to Garcia. He also noted recent approvals that expand access, including use in pediatric patients over age two and the ability for remote capsule ingestion, which management said aligns with telemedicine adoption.
Garcia said CapsoVision is seeing greater penetration in larger gastroenterology networks, including increased traction in hospital systems and group purchasing organizations, where the company is being evaluated against incumbent solutions. He stated that the number of hospital system customers increased 87% in the fourth quarter compared with the same period last year.
Pipeline updates: AI module, colon capsule, and pancreatic initiative
Wang said CapsoVision submitted a 510(k) application at the end of 2025 for an AI-assisted reading module for CapsoCam Plus intended to enhance lesion detection and streamline physician review.
For CapsoCam Colon, Wang said the company refined its development approach following interactions with the FDA, choosing to prioritize a second-generation system rather than continuing with a first-generation submission. He said Gen 2 is intended to incorporate improved imaging performance, an expanded field of view, and enhanced AI functionality. CapsoVision had enrolled over 400 patients in its pivotal study at the time of prepared remarks and was starting enrollment across U.S. sites. Wang said the company expects to submit a 510(k) for CapsoCam Colon Gen 2 and its AI module in the third quarter of 2026.
In the question-and-answer session, Wang provided additional details on the colon program:
- He said Gen 2 has higher resolution, higher image quality, and a larger field of view, along with improved software and integration with the AI module.
- He said enrollment was “over 500, but close to 600,” with 11 sites across the U.S., and that the company remained on track to file by the end of the third quarter, with no delays reported.
- Wang noted that physician vacation schedules during summer can be an “X factor” affecting enrollment pace, though he said the study was tracking to plan.
Asked about timing after submission, Wang said the company expects an FDA review period of about six months. Based on that assumption, he said CapsoVision expects clearance in the first quarter of 2027 and anticipated launching the product “the beginning of second half, 2027.”
Wang also discussed CapsoVision’s CapsoCam UGI program and its pancreatic cancer initiative, describing a proposed non-invasive screening approach focused on visual assessment of the duodenal wall and anatomical landmarks such as the papilla of Vater. He said the company received constructive FDA feedback following an initial breakthrough device designation submission, including confirmation of the system’s ability to visualize the papilla and associated abnormalities, alongside guidance to further define diagnostic criteria.
To address that, Wang said CapsoVision plans to initiate a clinical study expected to begin in the second quarter of 2026 enrolling approximately 60 to 90 patients to establish diagnostic criteria for malignancy using the CapsoCam UGI system. He said the work will be conducted with clinical experts and key opinion leaders, including leadership of professional societies in the pancreatobiliary field, and that the data is intended to support regulatory advancement and a future breakthrough designation resubmission. Wang added that the regulatory pathway for CapsoCam UGI is independent of the breakthrough program and “will remain on track.”
In response to an analyst question, Wang outlined a contemplated diagnostic scoring system that would grade multiple features associated with pancreatic cancer, including papilla abnormalities and duodenal wall changes caused by tumor compression or invasion. He said the scoring system would include graded features (yes/no and severity) and could incorporate multivariate factors such as gender and age, with the model built from study results. He said the study would be an important step for a breakthrough designation application, while noting that additional validation in a separate population may be needed because the same cohort used to build the model cannot be used to validate it.
Financial results and capital raise
For the fourth quarter of 2025, Garcia reported total revenue of $3.9 million, up 13% from the fourth quarter of 2024, driven by increased CapsoCam Plus capsule sales. Gross profit was $2.0 million, up $200,000, with gross margin of 50%, which he said was consistent with expectations as the business scales.
Operating expenses were $9.4 million, an increase of $3.1 million year over year. Garcia attributed the increase primarily to development expenses tied to new CMOS image sensors under an agreement with Canon, continued investment in the colon clinical study, and higher public company expenses.
CapsoVision ended 2025 with $10.1 million in cash and equivalents. Both Wang and Garcia discussed a subsequent $14 million private placement that management said strengthened the balance sheet. Garcia said the equity financing was completed at $4.88 per share, representing a 5% discount to the March 16 closing price under the agreement’s terms. He said net proceeds are intended to support commercial expansion, continued R&D investment, and advancement of pipeline programs, particularly CapsoCam Colon and the AI-enabled platform.
Outlook and priorities
In closing remarks, Wang said the company is entering “a highly competitive phase of execution” while building from a position of commercial strength in CapsoCam Plus. He emphasized continued traction in larger GI networks and hospital systems, ongoing investment in AI capabilities, and a “disciplined pipeline strategy” across colon and pancreatic initiatives, supported by the recent capital raise.
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.
