IceCure Logs Record $3.4M 2025 Sales, Plans 30 U.S. Hybrid Sites
IceCure reported record fourth-quarter sales of $1.3 million and full-year 2025 revenue of $3.4 million driven by FDA clearance of ProSense® cryoablation and updated American Society of Breast Surgeons guidelines. The company will add 30 hybrid commercial-clinical U.S. sites for its ChoICE post-marketing study targeting 400 patients over 36 months.
1. 2025 Financial Results
IceCure delivered record fourth-quarter sales of $1.3 million and full-year revenue of $3.4 million for 2025, marking its strongest annual performance to date.
2. Regulatory and Clinical Milestones
The company secured FDA clearance for ProSense® cryoablation in low-risk breast cancer, received updated ASBrS guidelines endorsing cryoablation, and applied to Health Canada to expand approval to early-stage breast cancer, potentially serving up to 7,130 eligible patients.
3. Commercial Expansion and Outlook
IceCure plans to establish 30 hybrid commercial-clinical U.S. sites for its ChoICE post-marketing study, which aims to enroll 400 patients over 36 months, while accelerating system installations and fostering adoption across hospitals and clinics.