IceCure Medical Ltd. (NASDAQ:ICCM) ("IceCure," "IceCure Medical" or the "Company"), developer of minimally-invasive cryoablation technology that destroys tumors by freezing as an option to surgical tumor removal, today announced that the Society of Interventional Oncology ("SIO") has submitted a formal petition (the "SIO 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 option for carefully selected patients with low-risk, early-stage breast cancer.
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The SIO Petition specifically proposes adding a Category 2B footnote recommending that percutaneous cryoablation without surgical excision may be considered as an alternative to breast-conserving surgery after shared decision-making, for patients aged 70 years or older with unifocal, ultrasound-visible invasive ductal carcinoma ≤1.5 cm, grade 1–2, hormone receptor-positive/HER2-negative, and clinically node-negative disease.
The SIO Petition further recommends the consideration of patients between the ages of 50-69 who are either poor surgical candidates or decline surgery when cryoablation is combined with whole-breast radiation therapy and endocrine therapy.
In support of its recommendation, the SIO Petition cited the U.S. Food and Drug Administration's ("FDA") marketing authorization of IceCure's ProSense® cryoablation system in October 2025. ProSense® is the first and only medical device to receive FDA marketing authorization specifically for the local treatment of biologically low-risk breast cancer in women aged 70 and older with tumors ≤1.5 cm who receive adjuvant endocrine therapy. The recommendation follows the March 2026 update to the American Society of Breast Surgeons (ASBrS) resource guide, which now supports cryoablation for appropriately selected patients with low-risk, early-stage breast cancer.
Potential Significance
Potential inclusion of cryoablation in the NCCN Breast Cancer Guidelines could increase clinical awareness and support broader consideration of this minimally invasive option for appropriately selected patients. Guideline recognition is often viewed as an important factor in clinical adoption and may influence reimbursement discussions over time.
The SIO is a professional organization focused on advancing interventional oncology through education, research, and advocacy.
The NCCN is a not-for-profit alliance of leading U.S. cancer centers that develops and publishes the widely used NCCN Clinical Practice Guidelines in Oncology. These guidelines are among the most influential evidence-based recommendations in cancer care and are frequently referenced by clinicians, institutions, and payers.