10-Q quarterly report · filed Nov 13, 2025

CapsoVision, Inc (CV) Q3 2025 10-Q Quarterly Report

Short answer

CapsoVision, Inc (CV) filed its Q3 2025 10-Q quarterly report on Nov 13, 2025 for the quarter ended Sep 30, 2025. Quarterly revenue was $4M with net income of −$8M.

Q3 2025 key financials · XBRL

Revenue
$4M
−42.0% QoQ
Net income
−$8M
+20.8% QoQ
Operating margin
-226.7%
Gross margin
54.1%
EPS (diluted)
$3.44
+176.6% QoQ

Source: XBRL data from the CapsoVision, Inc (CV) Q3 2025 10-Q on SEC EDGAR. USD.

CapsoVision, Inc Q3 2025 10-Q analysis

AI summary of MD&A and risk factor updates

Risk Factors

  • New risk: FDA Breakthrough Device Designation submitted for pancreatic cancer capsule endoscopy solution Nov 6, 2025, uncertain eligibility and authorization timing
  • Updated regulatory risk: Potential delays in FDA 510(k) clearance for CapsoCam Colon second-generation due to FDA staff reductions and government shutdowns still unresolved
  • Material regulatory risk: Dependence on FDA 510(k) clearance for CapsoCam Colon products, with failure causing reputational harm, lost sales, and increased liabilities
  • Operational risk: Supply chain concentrated in Asia (Taiwan, Japan) with single-source suppliers, vulnerable to geopolitical, trade, and natural disaster disruptions
  • Financial risk: Cash $17.8M as of Sep 30, 2025; substantial doubt as going concern; requires further capital raises risking dilution and impacting business continuity

Generated from the filing text; verify against the original. 10-K vs 10-Q vs 8-K

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