CapsoVision, Inc.

What they do

CapsoVision develops and sells a GI-tract capsule endoscopy system consisting of the single-use CapsoCam Plus capsule plus the CapsoCloud streaming and CapsoView download software for clinician video review. CapsoCam Plus is a Class II device cleared for visualizing small bowel mucosa in adults and children aged 2 and above; it received CE Mark in 2011, FDA 510(k) clearance in 2016, and U.S. commercial sales began in 2017. The company sells directly in the U.S. and both directly and through exclusive distributors internationally, using component suppliers and assembly manufacturers in Asia, particularly Taiwan and Japan. It is headquartered in Saratoga, California and was founded in 2005.

Revenue drivers

• CapsoCam Plus (small bowel capsule) — Essentially all revenue: $13.6 million in 2025 and $11.8 million in 2024, generated from sales of the CapsoCam Plus capsule. Revenue has grown each year since U.S. direct sales began in 2020, driven mainly by more capsules sold; use reached over 176,000 patients as of June 30, 2026.
• CapsoCloud / CapsoView software — Cloud-based and downloadable video review software sold with the capsule system; enables clinicians to stream or download capsule video 24/7 without an on-site server. No separate revenue figure is disclosed.
• AI Highlights (AI-assisted reading) — AI pathology detection tool for CapsoCam Plus. Launched commercially in the EU and other international markets in the second quarter of 2026; U.S. launch awaits expected FDA clearance. No revenue contribution disclosed.
• International sales — Sold both directly and through qualified exclusive distributors in specified regions; largest international shipping destinations in the first half of 2026 were France, Germany and Saudi Arabia, though no geographic revenue split is provided.

Recent performance

Second quarter 2026 revenue was $3.6 million, up 10% from $3.3 million in the second quarter of 2025, driven by a 13% increase in CapsoCam Plus capsules sold, partly offset by a roughly 3% decline in average selling price. Gross profit was $1.9 million with gross margin of 51%, down from 55% a year earlier on pricing pressure and higher customs and tariff costs. Operating expenses rose $3.0 million year over year to $9.5 million, primarily for the colon pivotal study and other trials, non-recurring engineering services for the Canon development project, public company costs and stock-based compensation. Cash and cash equivalents were $9.1 million as of June 30, 2026. Annual results show revenue of $13.6 million in 2025 versus $11.8 million in 2024, with net losses of $25.3 million and $19.9 million, respectively.

Strategy

CapsoVision is prioritizing development of its second-generation CapsoCam Colon capsule, which adds AI polyp detection and a 3D sensor-based polyp size measurement tool, after deciding not to pursue the first-generation colon product following FDA inquiries on panoramic image processing and study design. The company completed enrollment of 801 patients in the second-arm pivotal study and expects to submit a new 510(k) in the fourth quarter of 2026. It is also adding AI-assisted pathology detection to CapsoCam Plus, having submitted the related 510(k) in December 2025, and launched AI Highlights in the EU and other international markets. Beyond commercial execution with hospital systems and GI networks, the company expanded a CapsoCam UGI clinical study for pancreatic cancer detection and entered a sales agreement of up to $100 million for an at-the-market equity offering program with Cantor.

Risks

• Persistent net losses — CapsoVision incurred net losses of $25.3 million in 2025 and $19.9 million in 2024, had an accumulated deficit of $155.7 million as of December 31, 2025, and expects losses to continue in the foreseeable future.
• Regulatory clearance timing — U.S. and EU commercialization of the AI-enabled CapsoCam Plus and the second-generation CapsoCam Colon depends on FDA and EU clearances that may be delayed or never granted; the company already abandoned the first-generation colon submission after FDA feedback.
• Single-product concentration — Substantially all revenue comes from CapsoCam Plus, so pricing pressure, competitive capsule endoscopy offerings, or supply disruption from Asian component and assembly suppliers could directly hit results.
• Gross margin pressure — Gross margin fell to 51% in the second quarter of 2026 from 55% a year earlier due to competitive selling prices and increased U.S. customs and tariff expenses.

Outlook

Management anticipates FDA clearance of AI Highlights by the end of the third quarter of 2026 with U.S. commercial launch shortly thereafter, and says customer interest is strong ahead of that launch. The company expects to submit the 510(k) for the second-generation CapsoCam Colon in the fourth quarter of 2026 and continues enrolling the CapsoCam UGI study for pancreatic cancer detection. It also has access to an at-the-market equity program of up to $100 million, while reporting $9.1 million of cash as of June 30, 2026.