IceCure Medical Ltd Earnings Recaps
Q3 2025
Nov 19, 2025
IceCure Medical achieved a significant milestone with FDA marketing authorization for its ProSense system to treat low-risk breast cancer, positioning the company for enhanced growth and increased market penetration.
Key takeaways
- FDA authorization targets a market of approximately 200,000 patients annually, predominantly women over 70 or those ineligible for surgery.
- ProSense is expected to be the only cryoablation system cleared in the U.S. for breast cancer, imposing high barriers for potential competitors.
- Increasing interest from U.S. clinicians and commercial sites, with plans for a post-market study to expand utilization and adoption.
- Anticipated CPT code increase in January 2026 to over $4,000 will enhance reimbursement prospects, supporting broader patient access.
- Global interest is rising post-authorization, with expansions in markets where ProSense is already approved, including recent gains in Switzerland.
Q2 2025
Aug 13, 2025
IceCure Medical's first half of 2025 demonstrated strategic regulatory progress for its ProSense device despite a revenue decline attributed to external shipment delays, while strengthening its financial position through a successful rights offering.
Key takeaways
- Revenue fell to $1.25 million, down from $1.75 million due to shipment delays linked to the Israel-Iran conflict.
- Gross profit decreased to $349,000, resulting in a gross margin contraction to 28% from 46% year-over-year.
- The company closed a $10 million rights offering, significantly oversubscribed, providing a robust cash runway for anticipated FDA marketing authorization.
- Positive adoption trends in Europe were noted, driven by clinical evidence and a string of high-impact presentations at medical conferences.
- Anticipation of FDA approval for ProSense remains optimistic, with plans for a post-market study already submitted.