IceCure: SIO Petitions NCCN to Include Cryoablation in Breast Cancer Treatment Guidelines, Citing IceCure's FDA Clearance of ProSense®
Rhea-AI Summary
IceCure Medical (Nasdaq: ICCM) reported that the Society of Interventional Oncology (SIO) has submitted a formal petition to the NCCN Breast Cancer Guidelines Panel to include percutaneous cryoablation without surgical excision as a Category 2B treatment option for selected patients with low-risk, early-stage breast cancer.
The petition proposes cryoablation as an alternative to breast-conserving surgery for women aged 70+ meeting strict clinical criteria, and for patients aged 50–69 who are poor surgical candidates or decline surgery when combined with radiation and endocrine therapy. SIO cites the FDA’s October 2025 marketing authorization of IceCure’s ProSense system, the first device cleared for local treatment of biologically low-risk breast cancer in women 70+ with tumors ≤1.5 cm receiving adjuvant endocrine therapy. According to IceCure, potential NCCN inclusion could raise clinical awareness and influence future reimbursement discussions.
Positive
- FDA marketing authorization in October 2025 for ProSense for biologically low-risk breast cancer in women aged 70+ with tumors ≤1.5 cm receiving adjuvant endocrine therapy
- SIO petition to NCCN to add percutaneous cryoablation without surgical excision as a Category 2B option in breast cancer treatment guidelines for carefully selected low-risk, early-stage patients
Negative
- None.
Key Figures
Previous Fda approval Reports
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Jul 06 | FDA adoption update | Positive | -14.0% | Reported expanding Brazilian commercial adoption following FDA breast-cancer authorization. |
| Jun 17 | FDA install-base update | Positive | +200.5% | Reported 70% growth in the active U.S. commercial install base. |
| Mar 11 | FDA study approval | Positive | +8.9% | FDA approved the post-market ChoICE study design for low-risk breast cancer. |
| May 06 | FDA development update | Positive | +0.9% | Reported surgeon interest following positive FDA developments for ProSense cryoablation. |
| Apr 30 | FDA authorization progress | Positive | -0.8% | Outlined the FDA path toward ProSense marketing authorization and post-market study. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
FDA-tagged announcements produced three aligned positive reactions and two divergences, including a 13.99% decline after a commercial-adoption update.
Key Terms
cryoablation medical
percutaneous cryoablation medical
her2-negative medical
endocrine therapy medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
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
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
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
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
investors@icecure-medical.com
+1-888-902-5716
Logo - https://mma.prnewswire.com/media/2319310/IceCure_Medical_Logo.jpg
View original content:https://www.prnewswire.com/news-releases/icecure-sio-petitions-nccn-to-include-cryoablation-in-breast-cancer-treatment-guidelines-citing-icecures-fda-clearance--of-prosense-302837704.html
SOURCE IceCure Medical