CapsoVision (CV) investor relations material

Mission and technology

• Targeting one ingestible capsule to screen for esophageal, gastric, pancreatic, liver and colon cancers, with AI intended to identify precancerous lesions.

• Four laterally oriented cameras capture a 360-degree view, stitched into panoramic images; the capsule needs no external recorder or sensor arrays.

• Small-bowel capsule cecum completion rate cited at 98% vs. 84% for competitors; ampulla visibility cited at 80% vs. 10% for a competitor's lumen view.

• Patients can swallow the capsule at home and send it to a San Jose center for processing; imagery and AI-selected images are uploaded to the cloud for physician review anytime.

• AI reading time cited at several minutes for small bowel vs. 30 minutes, and 10–20 minutes for colon vs. more than one hour.

Commercial business and financials

• CapsoCam Plus is commercially sold for small-bowel use; Q2 revenue was $3.6M. Small-bowel capsule price is $425, cost is ~ $200, and capsules are single-use.

• FY2025 revenue was $13.6M, up 15% YoY; gross margin was 53%, and no debt was outstanding as of June 30.

• Direct sales teams operate in the U.S. and Germany, with distributors serving 69 countries; contracts include Premier and Vizient, and Kaiser Permanente uses the capsule as its primary small-bowel diagnostic modality.

• Portfolio includes 85 U.S.-issued patents; an $18M registered direct offering closed in September, and a $100M ATM was established in August.

• Small-bowel AI received FDA clearance in the prior month; U.S. launch was imminent, while international AI sales had begun.

Pipeline and market opportunity

• Colon pivotal study closed in August; FDA submission planned for November/Q4, with a response expected by June/July 2027.

• Colon capsule includes a 3D sensor to measure and locate polyps; colon use requires bowel prep, while telehealth supports completing the process at home.

• Colon capsule price cited at $600; reimbursement cited at ~ $1,000 through Medicare and $1,250–$1,300 for commercial payers.

• Colon screening market cited at $17.8B; the 10% of patients contraindicated for colonoscopy represents an estimated $1.8B opportunity.

• Pancreatic clinical study is underway; esophageal varices study is planned to start in H2 2027. Canon is designing a high-definition, high-dynamic-range sensor, due by year-end.