Financial Performance - Revenue for Q3 2025 was $3.5 million, a 19% increase from $2.966 million in Q3 2024, with U.S. growth at 25% and international growth at 3%[218]. - Revenue for the first nine months of 2025 was $9.636 million, up 16% from $8.304 million in the same period of 2024, with U.S. growth at 18% and international growth at 10%[219]. - Gross profit for Q3 2025 increased to $1.914 million, a 16% rise from $1.657 million in Q3 2024, while gross margin decreased from 56% to 54%[222]. - Net loss for Q3 2025 was approximately $7.921 million, a 37% increase from $5.794 million in Q3 2024[230]. - Total operating expenses for Q3 2025 were $9.933 million, a 33% increase from $7.460 million in Q3 2024[215]. - Costs of revenue for Q3 2025 increased by $0.315 million, or 24%, to $1.624 million compared to Q3 2024[221]. - As of September 30, 2025, the company had an accumulated deficit of $148.3 million, primarily funded through proceeds from convertible preferred stock sales, IPO proceeds, and revenue from CapsoCam capsules and related services[189]. - The company reported an accumulated deficit of $148.3 million as of September 30, 2025[231]. Research and Development - Research and development expenses rose to $6.090 million in Q3 2025, a 35% increase from $4.522 million in Q3 2024, driven by ongoing clinical trials and new product development[227]. - Research and development expenses include costs related to clinical trials and are subject to significant estimation uncertainty[250][251]. - The company is investing in AI to improve pathology detection accuracy and streamline diagnostic processes, leveraging a unique dataset from its CapsoCloud platform[195]. - The company is developing a capsule delivery device and a patency capsule, with FDA submissions planned for Q1 2026, to enhance its product offerings[192]. Regulatory and Product Development - The company filed a 510(k) submission to the FDA for the CapsoCam Colon capsule endoscopy solution in Q2 2025, with plans for a second-generation product submission in Q2 2026, aiming for FDA clearance by Q4 2026[183]. - The company plans to submit a 510(k) application for AI enhancements to CapsoCam Plus by the end of 2025, with commercialization expected shortly after FDA review[184]. - The company entered a development agreement with Canon Inc. for high-resolution CMOS image sensors to enhance future capsule endoscopies[186]. - The company is focused on expanding its small bowel capsule endoscopy market while preparing for the commercialization of the CapsoCam Colon capsule by the end of 2026[191]. Cash Flow and Financing - Net cash used in operating activities for Q3 2025 was $5.7 million, down from $7.1 million in Q3 2024[231]. - For the nine months ended September 30, 2025, net cash used in operating activities totaled $15.2 million, primarily driven by a net loss of $17.9 million[242]. - The company expects that its existing cash balances will not be sufficient to fund operations for at least the next 12 months, indicating a need for additional capital[236][237]. - Net cash provided by financing activities for the nine months ended September 30, 2025 was $23.6 million, compared to $10.1 million for the same period in 2024[241][246]. - The company may need to engage in equity or debt financings to secure additional funds, which could lead to significant dilution for existing stockholders[237][239]. - The company currently does not have any commitments to obtain additional funds and is evaluating different strategies for future funding[240]. Expenses and Cost Management - General and administrative expenses for Q3 2025 were $2.070 million, a 74% increase from $1.193 million in Q3 2024, primarily due to higher payroll and stock-based compensation[228]. - The company expects selling and marketing expenses to increase as it expands its sales organization and market penetration, but to decrease as a percentage of revenue as overall revenue grows[206]. - The company anticipates that gross profit and gross margin will be affected by various factors, including product costs and customer mix, particularly with the introduction of higher-priced CapsoCam Colon capsules[203]. - The company is addressing potential risks from U.S. trade policy changes, including increased tariffs, which could impact revenue and gross profit margins[202].
CapsoVision Inc(CV) - 2025 Q3 - Quarterly Report