IceCure Begins Postmarket Study of ProSense Cryoablation for Breast Cancer

October 26, 2026—IceCure Medical Ltd., developer of minimally invasive cryoablation technology, announced the enrollment of the first two patients at United States clinical sites in the postmarketing study evaluating ProSense cryoablation for the local treatment of low-risk breast cancer.

According to IceCure, the first patient in the United States postmarket study was enrolled by Richard E. Fine, MD, at West Cancer Center & Research Institute in Germantown, Tennessee. The second patient was enrolled by Dennis Holmes, MD, at Adventist Health Glendale in Glendale, California.

The company noted that these initial enrollments resulted from its efforts to establish a network of United States clinical sites for the ChoICE study. Both West Cancer Center and Adventist Health Glendale announced their eligibility to enroll patients in August 2026. In October, IceCure announced the addition of Legacy Health’s Legacy Medical Group—Surgical Oncology at Good Samaritan Medical Center in Portland, Oregon.

As explained in the press release, the ChoICE study is designed to enroll approximately 400 patients at up to 30 clinical sites in the United States to generate real-world data on ProSense in its FDA-cleared indication. Participating sites are expected to serve both as study centers and active commercial sites, enabling them to offer ProSense cryoablation to eligible patients who are not participating in the ChoICE study.

IceCure stated that its flagship ProSense system is marketed worldwide for the indications cleared and approved to date including in the United States, Europe, and Asia.

In October 2025, the company announced that the FDA has granted marketing authorization for its ProSense cryoablation system for the local treatment of early stage, biologically low-risk breast tumors (≤ 1.5 cm in size) in women aged ≥ 70 years—including patients who are not suitable for surgical alternative for breast cancer treatment—when combined with adjuvant endocrine therapy.

The FDA authorization was supported by data that included results from the multicenter ICE3 trial of liquid-nitrogen–based cryoablation in breast cancer. The results were published by Dr. Fine et al in Annals of Surgical Oncology (2024;31:7273-7283).