IceCure Celebrates American Society of Breast Surgeons' (ASBrS) Proposed Breast Cancer Treatment Guidelines Which Include Cryoablation for Low-Risk Breast Cancer

Rhea-AI Summary

IceCure (Nasdaq: ICCM) announced the American Society of Breast Surgeons' draft update to its resource guide would include cryoablation for select low‑risk breast cancer patients, aligning with the FDA's October 2025 marketing authorization. The draft covers patients ≥70 with ≤1.5 cm biologically low‑risk tumors and recommends cryoablation for fibroadenomas.

IceCure cited its ICE3 trial (5‑year local recurrence 3.1%) and reported growing U.S. commercial interest and installed systems across North America. The ASBrS comment period closed January 23, 2026; finalization is pending.

Positive

• ASBrS draft includes cryoablation for specified low‑risk breast cancer patients
• FDA marketing authorization (October 2025) aligns with proposed ASBrS guidance
• ICE3 trial 5‑year local recurrence of 3.1% demonstrates clinical efficacy
• Addressable U.S. population estimated at ~200,000 patients annually

Negative

• Guideline status pending finalization after open comment period ended January 23, 2026
• Indication limits to patients ≥70 years with tumors ≤1.5 cm narrow near‑term uptake

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ASBrS's updated "Resource Guide on the Use of Transcutaneous and Percutaneous Ablation for the Treatment of Benign and Malignant Tumors of the Breast" is pending finalization following the end of its open comment period on January 23, 2026

Inclusion of cryoablation in medical society guidelines is expected to result in more breast surgeons recommending cryoablation to appropriate patients

Finalized updated guidelines are expected to mark a major step towards widespread adoption of cryoablation in the United States and a new standard of care in breast cancer by offering a minimally invasive procedure that destroys tumors by freezing, without surgery

CAESAREA, Israel, Jan. 28, 2026 /PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure", "IceCure Medical" or the "Company"), a developer of minimally-invasive cryoablation technology that destroys tumors by freezing as an option to surgical tumor removal, today announced that the American Society of Breast Surgeons (ASBrS) is in the final stage of updating its "Resource Guide on Transcutaneous and Percutaneous Treatment of Benign and Malignant Tumors of the Breast" which should include cryoablation for the local treatment of breast cancer in patients aged ≥70 years, with biologically low-risk tumors measuring ≤1.5 cm, who are treated with adjuvant endocrine therapy, including patients who are not suitable candidates for surgery. The current draft of the proposed recommendation aligns with the U.S. Food and Drug Administration's ("FDA") marketing authorization granted in October 2025 for the use of cryoablation in the treatment of breast cancer. The proposed update to the ASBrS guidelines also recommends cryoablation for small benign tumors of the breast (fibroadenoma).

 

 

The proposed ASBrS guidelines follow a comment period which ended on January 23, 2026, during which medical professionals and industry members were invited to provide input on the proposed guidance. The proposed updates to the resource guide reflect the growing body of clinical evidence supporting breast cryoablation, including results from IceCure's ICE3 trial, the largest study of its kind in the U.S. and additional peer-reviewed publications. In the ICE3 study, only 3.1% of patients, with hormone receptor-positive and HER2-breast cancer treated locally with cryoablation and endocrine therapy (also known as hormone or hormonal therapy), experienced local recurrence of breast cancer within 5 years after treatment, demonstrating efficacy and safety similar to lumpectomy, while offering excellent cosmetic results and patient satisfaction.

"The proposed update to the ASBrS treatment guidelines represents an important step forward for breast cancer care," said Eyal Shamir, IceCure's Chief Executive Officer. "We are very pleased with the ASBrS's pending recognition that cryoablation can offer a meaningful minimally invasive option for the indicated patient population. ASBrS would be the first medical society to include cryoablation in its guidelines just three months following the FDA's clearance, and we hope other medical societies will do the same."

"We believe that cryoablation's inclusion in medical society guidelines will result in more breast surgeons recommending this minimally invasive procedure to appropriate patients, leading to better outcomes," Shamir added. "This is expected to lead to accelerated commercial adoption of cryoablation and support expanded reimbursement coverage as breast cryoablation becomes a standard-of-care treatment."

IceCure's U.S. commercial team continues to see accelerating interest in ProSense®. During recent months, systems were sold and installed at new locations across North America, including at one of the most highly regarded medical institutions in the U.S., reflecting growing clinical interest following the FDA's marketing authorization.

ProSense® addresses a U.S. breast cryoablation patient population of approximately 200,000 women annually, including an estimated 46,400 early-stage, low-risk breast cancer patients aged 70 and over, approximately 88,500 patients who are not candidates for breast cancer surgery, and roughly 63,000 patients with fibroadenomas who opt for excision.

About ProSense®

The ProSense® Cryoablation System is the first and only medical device to receive FDA marketing authorization for the local treatment of low-risk breast cancer with adjuvant endocrine therapy for women aged 70 and above, including patients who are not suitable for surgical alternatives for breast cancer treatment. A full list of benefits and risks can be found on the Company's website.

ProSense® is a minimally invasive cryosurgical tool that provides the option to destroy tumors by freezing them. The system uniquely harnesses the power of liquid nitrogen to create large lethal zones for maximum efficacy in tumor destruction in benign and cancerous lesions, including in the breast, kidney, lung, and liver.

ProSense® enhances patient and provider value by accelerating recovery, reducing pain, surgical risks, and complications. With its easy, transportable design and liquid nitrogen utilization, ProSense® opens the door to fast and convenient office-based procedures for breast tumors.

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 Statement

This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. Words such as "expects," "anticipates," "intends," "plans," "believes," "seeks," "estimates" and similar expressions or variations of such words are intended to identify forward-looking statements. For example, IceCure is using forward looking statements in this press release when it discusses: the proposed inclusion of cryoablation in medical society treatment guidelines; the expected impact of such inclusion on physician adoption, patient access, reimbursement coverage, and commercial adoption of ProSense®; the anticipated finalization of updated ASBrS guidelines; and the Company's expectations regarding the role of cryoablation as a minimally invasive treatment option for appropriately selected breast cancer patients. 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, 2024 filed with the SEC on March 27, 2025, 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.

IR Contact:

Email: investors@icecure-medical.com
Michael Polyviou
Phone: 732-232-6914

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SOURCE IceCure Medical

FAQ

What did IceCure (ICCM) announce about ASBrS guidelines on January 28, 2026?

IceCure said the ASBrS draft now proposes including cryoablation for select low‑risk breast cancer patients. According to the company, the draft covers patients aged ≥70 with tumors ≤1.5 cm and also recommends cryoablation for fibroadenomas.

How does the ASBrS proposed guidance align with FDA authorization for ICCM products?

The proposed ASBrS recommendation aligns with the FDA marketing authorization granted in October 2025. According to the company, this alignment supports clinical adoption and reflects the FDA's cleared local treatment indication for breast cryoablation.

What clinical evidence did IceCure (ICCM) cite to support cryoablation adoption?

IceCure highlighted its ICE3 trial showing a 3.1% local recurrence at five years. According to the company, ICE3 is the largest U.S. study of breast cryoablation and reports efficacy and safety comparable to lumpectomy for the indicated population.

What is the estimated U.S. patient population for breast cryoablation noted by IceCure (ICCM)?

IceCure estimates a U.S. addressable patient base of approximately 200,000 women annually. According to the company, this includes ~46,400 low‑risk patients aged 70+, ~88,500 non‑surgical candidates, and ~63,000 fibroadenoma patients.

What near‑term uncertainties remain after the ASBrS draft recommendation for cryoablation?

The draft is not yet final; the ASBrS comment period closed January 23, 2026 and final guidance remains pending. According to the company, finalization timing and uptake by other societies and payers could affect adoption and reimbursement pace.