CapsoVision Reports Third Quarter 2026 Financial Results
Key Highlights
- ➤Q3 revenue $3.6 million, compared with $3.5 million year over year
- ➤Q3 net loss $7.3 million, or $0.15 per share, improves year over year
- ➤AI Highlights received FDA clearance and launched commercially in the U.S. on November 2
- ➤CapsoCam Plus used by more than 184,000 patients worldwide as of September 30
- ➤$18 million registered direct offering generated approximately $17.8 million in net proceeds
Expert Statements
Johnny Wang, President and Chief Executive Officer of CapsoVision
“The FDA clearance and subsequent U.S. launch of AI Highlights marks an important step forward for CapsoVision”
Johnny Wang, President and Chief Executive Officer of CapsoVision
“Our four-camera, 360-degree panoramic capsule already provides physicians with a differentiated view of the small bowel.”
Johnny Wang, President and Chief Executive Officer of CapsoVision
“By combining that imaging capability with AI-assisted review, we believe we can reduce reading time, improve detection accuracy compared with manual review, and give physicians an additional level of diagnostic confidence.”
Johnny Wang, President and Chief Executive Officer of CapsoVision
“We believe the combination of panoramic imaging and FDA-cleared AI-assisted review, approved for use in patients two years and older is a meaningful differentiator for CapsoCam Plus.”
Johnny Wang, President and Chief Executive Officer of CapsoVision
“At the same time, completing enrollment in our colon clinical study brings us closer to our planned FDA submission by year end, which we believe represents a substantially larger market opportunity.”
Johnny Wang, President and Chief Executive Officer of CapsoVision
“With the support of our existing shareholders through our recent financing, we are focused on translating these milestones into broader adoption and long-term growth”
SARATOGA, Calif., Nov. 12, 2026 (GLOBE NEWSWIRE) -- CapsoVision, Inc. (NASDAQ: CV), a commercial-stage medical technology company developing advanced imaging and AI-enabled capsule endoscopy solutions, today reported financial results and provided a business update for its third quarter ended September 30, 2026.
Recent Highlights * Reported third quarter 2026 revenue of $3.6 million, compared with $3.5 million in the third quarter 2025. * CapsoCam Plus® used by more than 184,000 patients worldwide as of September 30, 2026, compared with 151,000 a year earlier. * Received FDA clearance for AI Highlights™, the Company’s AI-assisted reading tool for CapsoCam Plus®, on September 25, 2026, followed by its U.S. commercial launch on November 2, 2026. Available for both adults and pediatric patients aged two and older, AI Highlights supports physician review through both local computer and cloud-based platforms. The Company expects the addition of AI Highlights to accelerate CapsoCam Plus sales growth, with the full commercial impact anticipated in 2027. * Completed enrollment and clinical data collection for the second-generation CapsoCam Colon™ study, including physician review of capsule videos both with and without AI assistance. FDA 510(k) submission remains on track for year-end 2026. * Continued expanding the clinical footprint of the CapsoCam UGI study for pancreatic cancer detection. Building on two active community-based clinical sites, the Company has executed a clinical trial agreement with a third site and is in various stages of contracting and feasibility discussions with more than a dozen larger medical centers with expertise in pancreatic ductal adenocarcinoma (PDAC), which the Company expects will help accelerate patient enrollment. * Completed an $18 million registered direct offering with existing shareholders in September 2026, generating approximately $17.8 million in net proceeds. * Raised approximately $1.7 million in net proceeds through the at-the-market offering program during the third quarter of 2026. * Appointed David S. Shields, M.D., to the Board of Directors effective July 1, 2026. Management Commentary
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