IceCure Medical's ProSense® Cryoablation Gains FDA Approval for Breast Cancer Study

IceCure Medical's FDA Approval for ProSense® Cryoablation Study

IceCure Medical Ltd. has announced an important milestone in the battle against low-risk breast cancer with the U.S. Food and Drug Administration's (FDA) approval of the ChoICE Trial Post-Market Study for its ProSense® Cryoablation System. This pioneering system, which offers a minimally invasive alternative to traditional surgical methods, is specifically targeted at patients 70 years and older with low-risk tumors.

In October 2025, the FDA granted marketing authorization for ProSense®, aimed at patients aged 70 and above who have biologically low-risk tumors measuring less than or equal to 1.5 cm and are receiving adjuvant endocrine therapy. Following this, the FDA mandated that IceCure conduct a post-market surveillance study to gather further real-world data regarding the system's effectiveness and safety in clinical practice.

Study Details

The upcoming ChoICE Study will enroll approximately 400 patients across 30 clinical sites over a span of 36 months, beginning in the second half of 2026. IceCure has reported a strong interest from leading medical institutions in the United States looking to participate in this significant study. While the trial will focus on patient enrollment and treatment, participating sites will also provide cryoablation to additional patients not part of the study, thereby broadening the technology's commercial reach.

The study aims not only to demonstrate the efficacy of ProSense® but also to increase its availability as a treatment option, supported by an established CPT Category III reimbursement code, generating around $4,000 per procedure for participating facilities.

Expertise Behind the Trial

IceCure has enlisted renowned experts to lead this trial. Dr. Robert Ward, an Assistant Professor of Diagnostic Imaging at Brown University, and Dr. Nathalie McDowell Johnson, Senior Medical Director at Legacy Health Systems, will serve as Co-Principal Investigators. Their expertise in breast imaging and minimally invasive cancer treatments will guide the study's execution, ensuring high-quality data and clinical insights.

Dr. Ward, known for his extensive research and publications on cryoablation techniques, and Dr. Johnson, a former president of the American Society of Breast Surgeons, are committed to advancing the future of breast cancer treatments through innovation in cryoablation technology.

Advantages of ProSense® Technology

The ProSense® Cryoablation System stands out as the first FDA-approved technology for low-risk breast cancer treatment among senior patients. This system leverages liquid nitrogen to achieve substantial freezing of tumors, thus creating large lethal zones that enhance the treatment's effectiveness. Its minimally invasive nature allows for reduced recovery times, diminished surgical risks, and significant pain reduction compared to traditional methods. As a result, procedures utilizing ProSense® can be efficiently performed in outpatient settings, ensuring quick patient recovery and convenience.

IceCure Medical aims to leverage the recent FDA approval and the supportive guidelines from the American Society of Breast Surgeons to significantly improve access to this crucial treatment option. The ongoing collaborative relations with clinical sites will also serve as a commercial avenue to expand the reach of the ProSense® technology.

As we look forward to the commencement of the ChoICE Study, this innovative approach could illuminate new paths for treating low-risk breast cancer, ultimately transforming patient care and treatment options in the U.S. and beyond.

For more information about IceCure Medical and their ProSense® Cryoablation System, visit their official website.