IceCure: SIO Petitions NCCN to Include Cryoablation in Breast Cancer Treatment Guidelines, Citing IceCure's FDA Clearance of ProSense®

The petition by The Society of Interventional Oncology (SIO) includes adding criteria for patients aged 50-69 who are poor surgical candidates or who decline surgery in the National Comprehensive Cancer Network (NCCN) treatment guidelines, expanding the current eligible population of patients aged 70 and above

CAESAREA, Israel, July 29, 2026 /PRNewswire/ -- 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.

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.

About IceCure Medical

IceCure Medical (Nasdaq: ICCM) develops and markets advanced liquid-nitrogen-based cryoablation therapy systems for the destruction of tumors (benign and cancerous) by freezing, with the primary focus areas being breast, kidney, bone and lung cancer. Its minimally invasive technology is a safe and effective option to surgical tumor removal that is easily performed in a relatively short procedure. The Company's flagship ProSense® system is marketed and sold worldwide for the indications cleared and approved to date including in the U.S., Europe, and Asia.

Forward Looking Statements

This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that are intended to be covered by the "safe harbor" created by those sections. Forward-looking statements, which are based on certain assumptions and describe our future plans, strategies and expectations, can generally be identified by the use of forward-looking terms such as "believe," "expect," "may," "should," "could," "seek," "intend," "plan," "goal," "estimate," "anticipate" or other comparable terms. For example, the Company is using forward-looking statements when it discusses the NCCN's consideration of and potential response to the SIO Petition; the potential inclusion of percutaneous cryoablation without surgical excision as a Category 2B option in the NCCN Breast Cancer Guidelines; the potential expansion of the patient population for whom cryoablation may be considered; and the potential for guideline recognition to increase clinical awareness, support broader clinical consideration or adoption of cryoablation and ProSense®, and influence reimbursement discussions over time. Historical results of scientific research and clinical and preclinical trials do not guarantee that the conclusions of future research or trials will suggest identical or even similar conclusions. Important factors that could cause actual results, developments and business decisions to differ materially from those anticipated in these forward-looking statements include, among others: the Company's planned level of revenues and capital expenditures; the Company's available cash and its ability to obtain additional funding; the Company's ability to market and sell its products; legal and regulatory developments in the United States and other countries; the Company's ability to maintain its relationships with suppliers, distributors and other partners; the Company's ability to maintain or protect the validity of its patents and other intellectual property; the Company's ability to expose and educate medical professionals about its products; political, economic and military instability in the Middle East, specifically in Israel; as well as those factors set forth in the Risk Factors section of the Company's Annual Report on Form 20-F for the year ended December 31, 2025 filed with the SEC on March 17, 2026, and other documents filed with or furnished to the SEC which are available on the SEC's website, www.sec.gov. The Company undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law.

Investor Relations: Meir Peleg
[email protected]
+1-888-902-5716

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SOURCE IceCure Medical