IceCure's U.S. Cryoablation Install Base Surges 70% Post-FDA Clearance

Event summary

  • IceCure's U.S. active commercial install base for ProSense® breast cancer cryoablation systems grew 70% following FDA clearance in October 2025.
  • Procedures performed in major U.S. cities including Los Angeles, New York, and Atlanta.
  • Significant increase in sales leads at SBI and ASBrS conferences compared to 2025.
  • ASBrS updated guidelines to recommend cryoablation for low-risk breast cancer patients.
  • Media coverage across 190 CBS and CW-affiliated stations increased patient awareness.

The big picture

IceCure's rapid install base growth reflects the FDA's October 2025 clearance and increasing clinical acceptance of cryoablation as a viable alternative to surgery for low-risk breast cancer. The company's strategic focus on physician training and patient awareness positions it to capitalize on the early stages of a significant commercial opportunity in the U.S. healthcare market. The updated ASBrS guidelines and media coverage further validate the growing recognition of cryoablation's potential role in breast cancer treatment.

What we're watching

Clinical Adoption
Whether the updated ASBrS guidelines will accelerate physician adoption of cryoablation for low-risk breast cancer patients.
Market Penetration
The pace at which IceCure can expand its U.S. footprint beyond major metropolitan areas.
Competitive Dynamics
How traditional surgical options and other minimally invasive treatments will respond to the growing acceptance of cryoablation.