FDA Greenlights IceCure’s ProSense® Study for Breast Cancer

The U.S. Food and Drug Administration (FDA) has given the green light to IceCure Medical Ltd. for a post-marketing study of their ProSense® cryoablation technology. This significant approval allows IceCure to begin the “ChoICE Trial Post-Market Study” in treating low-risk breast cancer in patients aged 70 and older. The study aims to enroll 400 patients across 30 U.S. clinical sites, offering a less invasive alternative to traditional surgical procedures.

IceCure, known for its minimally-invasive tumor-cryoablation technology, secures FDA approval to explore ProSense®’s effectiveness in treating breast cancer. Following the FDA’s marketing authorization in October 2025 for use in select older patients, the agency now requests further data through this post-market surveillance study. The approval is a pivotal step toward establishing ProSense® as a standard treatment, supported by established CPT Category III reimbursement codes that can facilitate broader adoption in medical institutions. This development positions IceCure favorably in the expanding market of minimally invasive cancer treatments, reflecting the company’s commitment to advancing patient care and clinical outcomes.

With the FDA’s endorsement and collaboration from leading medical professionals like Dr. Robert Ward and Dr. Nathalie Johnson, IceCure is poised to reshape breast cancer treatment options for older patients. This study symbolizes a crucial evolution in cryoablation technology, enhancing IceCure’s commercial prospects and opening the door to innovative, less invasive treatments in the fight against cancer.