CAESAREA, Israel, July 29, 2026
IceCure Medical Ltd. has announced a significant development that could broaden the role of minimally invasive cryoablation in the treatment of early-stage breast cancer. The Society of Interventional Oncology (SIO) has submitted a formal petition to the National Comprehensive Cancer Network (NCCN) Breast Cancer Guidelines Panel, requesting the inclusion of percutaneous cryoablation without surgical excision as a Category 2B treatment option for carefully selected patients with low-risk, early-stage breast cancer. The petition is supported by the U.S. Food and Drug Administration (FDA) marketing authorization granted to IceCure’s ProSense® cryoablation system in October 2025, making it the first and only FDA-authorized medical device specifically indicated for the local treatment of biologically low-risk breast cancer in women aged 70 years and older. If accepted, the proposed guideline update could expand patient eligibility, increase physician awareness, and strengthen the clinical adoption of cryoablation as a non-surgical alternative for selected breast cancer patients.
SIO Petition Proposes Expanded NCCN Treatment Guidelines
The SIO petition requests that the NCCN Breast Cancer Guidelines include percutaneous cryoablation without surgical excision as a Category 2B recommendation for appropriately selected patients with unifocal, ultrasound-visible invasive ductal carcinoma measuring 1.5 cm or smaller, classified as grade 1–2, hormone receptor-positive, HER2-negative, and clinically node-negative. While the proposed recommendation continues to support women aged 70 years and older, it also recommends expanding eligibility to include patients aged 50–69 years who are either poor surgical candidates or choose to decline surgery, provided cryoablation is combined with whole-breast radiation therapy and endocrine therapy. This proposed expansion reflects growing clinical interest in offering less invasive treatment options that preserve quality of life while maintaining effective local tumor control for carefully selected patients with early-stage disease.
FDA-Cleared ProSense® Supports Minimally Invasive Cancer Care
The petition cites the FDA marketing authorization of IceCure’s ProSense® cryoablation system, which became the first medical device specifically authorized in the United States for treating biologically low-risk breast cancer using cryoablation. The ProSense® system utilizes advanced liquid nitrogen-based cryoablation technology to destroy tumors by precisely freezing cancerous tissue, offering a minimally invasive alternative to traditional surgical tumor removal. The recommendation also builds upon updated guidance published by the American Society of Breast Surgeons (ASBrS) in March 2026, which supports the use of cryoablation in appropriately selected patients with low-risk, early-stage breast cancer. Together, these developments demonstrate increasing recognition of image-guided cryoablation as an important treatment option capable of reducing surgical burden while maintaining effective local disease management.
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Guideline Recognition Could Accelerate Clinical Adoption
Potential inclusion of cryoablation within the NCCN Clinical Practice Guidelines in Oncology could represent a major advancement for the field of interventional oncology and minimally invasive breast cancer treatment. The NCCN Guidelines are among the most widely referenced evidence-based recommendations used by oncologists, healthcare institutions, and insurance providers when making treatment decisions. Inclusion of ProSense®-supported cryoablation could significantly increase physician awareness, encourage broader clinical adoption, and potentially support future reimbursement discussions for eligible patients. As healthcare continues to emphasize personalized medicine, minimally invasive procedures, and improved patient quality of life, IceCure Medical’s technology may play an increasingly important role in expanding treatment choices for women diagnosed with early-stage breast cancer. While the NCCN Guidelines Panel has not yet issued a decision on the petition, the submission represents an important milestone in advancing evidence-based, patient-centered innovations in cancer care.
Source: IceCure Medical press release
