Four Studies Evaluate IceCure’s ProSense Cryoablation System to Treat Breast Cancer

December 17, 2025—IceCure Medical Ltd. announced that four abstracts featuring data from independent clinical studies conducted in Spain and Italy using the company’s ultrasound-guided ProSense cryoablation system were presented at RSNA 2025, the annual meeting of the Radiological Society of North America.

According to the company, the studies evaluated percutaneous cryoablation as a minimally invasive option for patients with breast cancer who were not candidates for surgery or who declined surgical treatment. The abstracts focused on outcomes, comparative effectiveness, and imaging-based follow-up after ultrasound-guided cryoablation of breast tumors in a population that is often elderly or medically inoperable and for whom alternatives to surgery are limited, noted IceCure.

As outlined in the company’s press release, the four abstracts included the following:

1. Laura Abelairas Lopez, MD, et al reported on a single-center experience in Spain that evaluated percutaneous cryoablation for local control of breast cancer in nonsurgical patients. The key finding was that percutaneous cryoablation was successful in 100% of luminal cancers up to 2.5 cm. Additionally, complete tumoral necrosis was achieved in 81.2% of tumors overall with no major complications.
2. Federica Di Naro, MD, et al compared three nonsurgical strategies in 111 surgery-ineligible patients: cryoablation combined with hormonal therapy (HT), cryoablation alone, and HT alone. Tumor size reduction differed significantly among groups (P = .0005), with the greatest reduction observed in the cryoablation-with-HT group.
3. Dr. Di Naro et al conducted a study demonstrating a significant association between lesion conspicuity on 12-month contrast-enhanced mammography (CEM) and biopsy results, with absent or low enhancement correlating with negative histology and a reported negative predictive value of 100%.
4. Dr. Abelairas Lopez et al outlined mammography, ultrasound, and CEM findings that may help identify successful treatment or residual disease without routine biopsy.

Full summaries with data from the four presentations as well as links to the RSNA abstracts are provided on IceCure’s press release, here.

In October 2025, IceCure announced that the FDA granted marketing authorization for the ProSense cryoablation system for the local treatment of early stage, biologically low-risk breast cancer in women ages ≥ 70 years—including patients who are not suitable for surgical alternatives for breast cancer treatment—when combined with adjuvant endocrine therapy.