IceCure Medical Ltd. (Nasdaq: ICCM) (“IceCure”), a developer of minimally invasive cryoablation technology, announced that the American Society of Breast Surgeons (ASBrS) is in the final stages of updating its “Resource Guide on the Use of Transcutaneous and Percutaneous Ablation for the Treatment of Benign and Malignant Tumors of the Breast.”
The updated guidelines are expected to include cryoablation as a treatment option for certain breast cancer patients, specifically those aged 70 and older with biologically low-risk tumors measuring 1.5 cm or less who are receiving adjuvant endocrine therapy, as well as patients unsuitable for surgery. The draft recommendation also covers the use of cryoablation for small benign breast tumors such as fibroadenomas.
This update aligns with the U.S. Food and Drug Administration’s (FDA) marketing authorization granted in October 2025 for cryoablation in breast cancer treatment. The ASBrS’s open comment period on the proposed guidance ended on January 23, 2026, allowing medical professionals and industry stakeholders to provide feedback.
The proposed guideline changes are supported by a growing body of clinical evidence, including results from IceCure’s ICE3 trial, the largest U.S. study of its kind. In the ICE3 trial, only 3.1% of patients with hormone receptor-positive, HER2-negative breast cancer treated with cryoablation and endocrine therapy experienced local recurrence within five years, demonstrating safety and efficacy comparable to lumpectomy while offering improved cosmetic outcomes and patient satisfaction.
“The proposed update to the ASBrS treatment guidelines represents a significant advancement in breast cancer care,” said Eyal Shamir, CEO of IceCure. “The recognition of cryoablation as a minimally invasive option for the indicated patient population could transform standard treatment practices in the U.S.”
Shamir noted that inclusion in medical society guidelines is expected to increase recommendations for cryoablation among breast surgeons, accelerate commercial adoption, and support expanded reimbursement coverage, positioning cryoablation as a standard-of-care treatment for eligible patients.
IceCure’s U.S. commercial team has reported growing demand for its ProSense® Cryoablation System, with recent installations at leading medical institutions across North America following FDA approval.
ProSense® is FDA-cleared for local treatment of low-risk breast cancer in women aged 70 and older, including patients unsuitable for surgery, and is also indicated for benign tumors such as fibroadenomas. The minimally invasive system uses liquid nitrogen to destroy tumors by freezing, reducing surgical risks, complications, and recovery time, and enabling office-based procedures.
IceCure Medical develops and markets advanced cryoablation systems for tumors in the breast, kidney, bone, and lung. Its flagship ProSense® system is marketed globally for approved indications, offering a safe, minimally invasive alternative to surgery.
