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CapsoVision (CV) investor relations material
CapsoVision Q3 2025 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Executive summary
Q3 2025 revenue grew 19% year-over-year to $3.5 million, driven by increased CapsoCam Plus sales and expanded U.S. and international market penetration.
New account generation increased 31% year-over-year, with over 151,000 patients having used CapsoCam Plus as of September 30, 2025.
Expanded pipeline with FDA submission for AI-enabled CapsoCam Plus and Breakthrough Device Designation for pancreatic cancer screening.
Entered a development agreement with Canon for next-generation CMOS imaging sensors to enhance future capsule endoscopes.
Completed IPO in July 2025, raising $23.4 million in net proceeds, converting all preferred stock to common stock, and appointing a new SVP of Finance.
Financial highlights
Q3 2025 revenue: $3.5 million (up 19% year-over-year); nine months: $9.6 million (up 16%).
Gross margin for Q3 2025 was 54%, down from 56% in Q3 2024, with gross profit at $1.9 million.
Operating expenses rose to $9.9 million for Q3 2025, mainly due to R&D and G&A costs.
Net loss for Q3 2025 was $7.9 million, compared to $5.8 million in Q3 2024.
Cash and equivalents totaled $17.8 million as of September 30, 2025, boosted by $23.4 million in IPO proceeds.
Outlook and guidance
FDA submission for AI-enabled CapsoCam Plus expected by year-end 2025, with clearance and commercialization anticipated in the second half of 2026.
CapsoCam Colon Gen-2 pivotal study underway, with FDA submission targeted for Q2 2026 and potential clearance in Q4 2026.
Canon CMOS sensor integration expected in 2027; current pivotal studies will use existing Toshiba sensors with improved optics.
Management expects continued losses and negative cash flows until further revenue growth and break-even are achieved; existing cash is not sufficient to fund operations for the next 12 months.
Sales team expansion planned for 2026, with two new territories in large U.S. markets.
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