The Society of Interventional Oncology (SIO) submitted a formal petition to the National Comprehensive Cancer Network (NCCN) Breast Cancer Guidelines Panel on July 29, 2026, requesting the inclusion of percutaneous cryoablation without surgical excision as a Category 2B treatment option. The move aims to expand clinical adoption of minimally invasive tumor destruction for carefully selected patients with low-risk, early-stage breast cancer, potentially influencing reimbursement and standard-of-care protocols across U.S. oncology centers. IceCure Medical Ltd. (NASDAQ: ICCM), developer of the ProSense® cryoablation system, highlighted the petition as a significant step toward broader guideline recognition.

The SIO Petition specifically proposes adding a Category 2B footnote recommending that percutaneous cryoablation may be considered as an alternative to breast-conserving surgery after shared decision-making. This recommendation targets 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 petition further recommends considering patients between the ages of 50-69 who are either poor surgical candidates or decline surgery, provided cryoablation is combined with whole-breast radiation therapy and endocrine therapy.

In support of its recommendation, the SIO cited the U.S. Food and Drug Administration’s marketing authorization of IceCure Medical Ltd.’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.

Key Criteria for Proposed Guideline Inclusion

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 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, which are among the most influential evidence-based recommendations in cancer care.

What the Numbers Show

The strategic alignment between regulatory approval and professional society advocacy highlights a clear pathway for market expansion. By leveraging the October 2025 FDA clearance of ProSense®, the SIO is pushing for guideline recognition that mirrors the approved indication while extending it to a broader demographic (ages 50-69) under specific clinical constraints. This suggests that IceCure Medical is positioning its technology not just as a niche alternative for elderly patients, but as a viable standard-of-care option for middle-aged patients who cannot or choose not to undergo surgery, contingent upon combined therapy protocols.

IceCure Medical Ltd. reported growing commercial adoption of its ProSense cryoablation system in Brazil following a recent U.S. FDA marketing authorization for early-stage, low-risk breast cancer. The company highlighted this expansion at the SOBRICE Onco 2026 congress, noting that the FDA clearance has significantly boosted awareness among Brazilian physicians and institutions. IceCure CEO Eyal Shamir stated that commercial procedures are already being performed for breast, lung, kidney cancer, and musculoskeletal tumors in the country.

The ProSense system holds Agência Nacional de Vigilância Sanitária (ANVISA) regulatory approval in Brazil. IceCure believes the U.S. FDA authorization has provided a tailwind for market penetration in Brazil's interventional oncology sector. The company is working with KTR Medical, its exclusive distributor in Brazil, to expand access to the technology through clinical education and strategic partnerships.

Clinical validation efforts are accelerating with large-scale independent studies. Dr. Vanessa Sanvido, a breast surgeon at HCor Hospital in São Paulo, is leading a study involving 750 patients across Brazil. In France, Dr. Toulsie Ramtohul of Institut Curie is planning a two-arm study with 900 patients to evaluate cryoablation against the current standard of care. Dr. Ramtohul also conducted master classes at Albert Einstein hospital in São Paulo to share clinical expertise.

Clinical Studies Overview

Key medical centers in Brazil are adopting the technology, advocated by experts such as Dr. José Hugo Luz of the Instituto Nacional De Câncer. IceCure positions ProSense as a minimally invasive alternative to surgery, offering shorter recovery times and improved quality of life for patients.