IceCure Medical Reports Record Sales on FDA Clearance Tailwinds

Event summary

  • IceCure Medical reported record 2025 sales of $3.4M, up from $3.3M in 2024, driven by FDA clearance for low-risk breast cancer treatment.
  • The company plans to add 30 hybrid commercial-clinical sites for its FDA-approved post-marketing study in the U.S.
  • Submitted a Class III amendment application to Health Canada to expand regulatory approval for ProSense® in low-risk breast cancer.
  • Gross margin declined to 36% in 2025 from 44% in 2024 due to increased costs and reduced revenue from Japan.
  • Cash reserves increased to $8.9M as of December 31, 2025, up from $7.6M a year earlier.

The big picture

IceCure Medical's record sales reflect the growing acceptance of its ProSense® cryoablation system following FDA clearance for low-risk breast cancer. The company is positioning itself for further expansion through regulatory approvals and increased commercial adoption. The decline in gross margin highlights the challenges of scaling operations, but the strategic focus on key markets and reimbursement improvements could drive long-term growth.

What we're watching

Regulatory Expansion
Whether IceCure can secure additional regulatory approvals in Canada and Japan, which would significantly expand its market reach.
Commercial Adoption
The pace at which the 30 new hybrid commercial-clinical sites will drive adoption of ProSense® in the U.S.
Reimbursement Dynamics
How potential increases in CPT code reimbursement could impact the company's financial performance in 2027 and beyond.