Earnings summaries and quarterly performance for CapsoVision.
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Recent press releases and 8-K filings for CV.
CapsoVision Submits 510(k) Application for AI-Assisted Module in CapsoCam Plus
CV
Product Launch
New Projects/Investments
- CapsoVision, Inc. (CV) announced the submission of its 510(k) application to the FDA for an AI-assisted module for its CapsoCam Plus® system on December 29, 2025.
- The new module is designed to improve the detection of clinically significant pathology and reduce clinician review time.
- The company intends to commence U.S. commercialization of the AI-assisted module following FDA clearance.
Dec 29, 2025, 9:10 PM
CapsoVision Reports Q3 2025 Results, Completes IPO, and Advances Pipeline
CV
Earnings
New Projects/Investments
Revenue Acceleration/Inflection
- CapsoVision reported Q3 2025 revenue of $3.5 million, marking 19% year-over-year growth, alongside a net loss of $7.9 million.
- The company completed an Initial Public Offering (IPO) on July 3, 2025, securing $23.4 million in net proceeds and boosting cash and equivalents to $17.8 million by quarter-end.
- Patient usage of the CapsoCam Plus system grew 20% year-over-year to approximately 8,336 patients in Q3 2025, contributing to over 151,000 patients served to date.
- Key pipeline developments include plans to submit AI technology for CapsoCam Plus to the FDA by year-end 2025, an application for Breakthrough Device Designation for pancreatic cancer detection, and ongoing progress with the CapsoCam Colon program.
- Operating expenses rose to $9.9 million in Q3 2025, including a $1.6 million one-time R&D expense related to a development agreement with Canon Incorporated.
Nov 13, 2025, 9:30 PM
CapsoVision Reports Q3 2025 Financial Results
CV
Earnings
Management Change
New Projects/Investments
- CapsoVision reported revenue of $3.5 million for the third quarter ended September 30, 2025, marking a 19% increase over the third quarter of 2024.
- Gross profit for Q3 2025 was $1.9 million, a 16% increase compared to the third quarter of 2024, with a gross margin of 54%.
- The company recorded a net loss of $7.9 million for the third quarter of 2025, with operating expenses increasing by $2.5 million to $9.9 million compared to the same period in 2024.
- As of September 30, 2025, cash and cash equivalents totaled $17.8 million. The company completed an initial public offering in July 2025, generating $23.4 million in net proceeds.
- Operational highlights include a 31% growth in new accounts in Q3 2025, over 151,000 patients using CapsoCam Plus, and the submission of an FDA application for Breakthrough Device Designation for early-stage pancreatic cancer detection. David Garcia was appointed Senior Vice President of Finance, effective November 3, 2025.
Nov 13, 2025, 9:07 PM
CapsoVision Submits FDA Breakthrough Device Designation Application
CV
New Projects/Investments
Product Launch
- CapsoVision, Inc. submitted an application to the U.S. Food and Drug Administration (FDA) on November 6, 2025, requesting Breakthrough Device Designation (BDD) for its CapsoCam UGI capsule endoscopy system.
- This application aims to accelerate the development of the system for early-stage pancreatic cancer detection, a disease with a five-year survival rate of only 8%.
- The CapsoCam UGI is a non-invasive capsule endoscopy system designed to visualize the duodenal papilla, which could indicate pancreatic abnormalities.
- The FDA's Breakthrough Devices Program expedites the development and review of technologies that may offer more effective diagnosis or treatment for life-threatening conditions without adequate alternatives.
Nov 10, 2025, 9:09 PM
Quarterly earnings call transcripts for CapsoVision.
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