American Society of Breast Surgeons (ASBrS) Resource Guide Update Recommends Cryoablation for Low-Risk Breast Cancer
Rhea-AI Summary
IceCure Medical (Nasdaq: ICCM) said the American Society of Breast Surgeons' 2026 Resource Guide now recommends cryoablation as an option for selected biologically low-risk early-stage breast cancer patients. The update follows FDA marketing clearance for ProSense® in October 2025 and cites clinical evidence and multidisciplinary care principles.
The guide affirms cryoablation for fibroadenomas and recognizes ProSense® as the first FDA-cleared device for low-risk breast cancer, potentially accelerating commercial adoption, aided by an established CPT III reimbursement code and an estimated U.S. addressable population of ~200,000 women annually.
Positive
- ASBrS guidance recommends cryoablation for low-risk breast cancer
- FDA marketing clearance achieved in October 2025 for ProSense
- Established CPT III reimbursement code supports adoption
- Estimated U.S. addressable population of ~200,000 women annually
- ProSense identified as the first FDA-cleared breast cryoablation device
Negative
- Indication limited to patients aged ≥70 years
- Tumor size restriction: ≤1.5 cm
- Treatment requires concurrent adjuvant endocrine therapy
Key Figures
Market Reality Check
Peers on Argus
Peer moves were mixed, with LUNG down 5.40% and VNRX up 5.86%, suggesting no clear sector-wide trend aligning with ICCM’s setup.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Mar 02 | Clinical study data | Positive | +10.1% | Independent PLOS One study showed ProSense® effective for breast fibroadenomas. |
| Feb 23 | Clinical trial update | Positive | +0.1% | Completed five-year follow up in ICESECRET kidney cancer cryoablation study. |
| Feb 19 | Commercial adoption | Positive | -0.1% | Thomas Hospital installed ProSense®, first in Alabama for breast cryoablation. |
| Feb 11 | Commercial adoption | Positive | -1.8% | Shero Imaging became first Missouri site offering breast cancer cryoablation. |
| Feb 09 | Management change | Neutral | +1.8% | Planned CFO departure with search underway and transition support outlined. |
Positive clinical and commercialization updates have sometimes led to aligned gains, but several favorable site-adoption releases saw modest or negative next-day reactions.
In recent months, IceCure highlighted growing evidence and commercialization for ProSense®, including PLOS One data in fibroadenomas with strong volume reduction, five-year follow-up completion in the ICESECRET kidney cancer study, and new breast cryoablation sites in Alabama and Missouri. A CFO transition was also announced alongside recognition of prior milestones such as Nasdaq listing and FDA clearance. Today’s ASBrS Resource Guide update, which recommends cryoablation for biologically low-risk breast cancer, extends this trajectory of guideline and clinical validation following the October 2025 FDA marketing clearance.
Market Pulse Summary
This announcement highlights ASBrS 2026 guidance recommending cryoablation as an option for selected biologically low-risk early-stage breast cancer patients, building on ProSense®’s FDA marketing clearance from October 2025. It reinforces the system’s role in older patients with small tumors who receive adjuvant endocrine therapy and fits alongside prior evidence in fibroadenomas and kidney cancer. Investors may watch how quickly guideline support expands use within the estimated 200,000-patient U.S. breast cryoablation population and translates into additional system placements and procedures.
Key Terms
cryoablation medical
fibroadenomas medical
AI-generated analysis. Not financial advice.
IceCure's ICE3 study and the FDA Advisory Panel's favorable vote on ProSense® cryoablation's benefit-risk profile for low-risk breast cancer played a key role in the ASBrS 2026 Resource Guide update
New medical society guidance expected to further accelerate commercial adoption of ProSense® following FDA-clearance for low-risk breast cancer in October 2025
"We believe this recognition by the ASBrS, a leading professional society, further validates cryoablation's role in modern breast cancer care and positions ProSense® as an option that prioritizes outcomes, cosmetic results, and patient choice," said Eyal Shamir, IceCure's Chief Executive Officer. "The ASBrS Resource Guide on percutaneous ablation compliments their recent guidance for breast-conserving treatment, emphasizing preservation, de-escalation, and individualized care. Cryoablation aligns naturally with these principles by providing minimally invasive, breast-preserving local tumor control without surgical excision."
IceCure's Vice President of Sales for
The ASBrS 2026 Resource Guide continues to recognize cryoablation as a validated, cosmetically favorable treatment for benign fibroadenomas and now identifies it as a carefully selected, FDA-approved option to surgery for biologically low-risk early-stage breast cancer in older patients. The guide indicates that cryoablation must be considered in the context of a comprehensive treatment plan with input from a multidisciplinary team. The ASBrS recommendations align clinical evidence, FDA authorization, and multidisciplinary care principles into a unified framework for the use of breast cryoablation.
Based on data from the American Cancer Society, ProSense® addresses a
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
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 expected impact of the of the ASBrS 2026 Resource Guide update on physician adoption, patient access, reimbursement coverage, and commercial adoption of ProSense®; the Company's belief that ProSense® is positioned as a treatment option that prioritizes outcomes, cosmetic results, and patient choice; that the ASBrS guidance is expected to further accelerate commercial adoption of ProSense® following FDA-clearance for low-risk breast cancer in October 2025; 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 guidance on March 9, 2026?
What is the FDA clearance status of ProSense® (ICCM) for breast cancer?
How large is the U.S. addressable market for ProSense® according to IceCure?
Will the ASBrS guidance affect commercial adoption of ProSense® (ICCM)?
Who are appropriate candidates for ProSense® cryoablation under the new guidance?
Does the ASBrS guide change cryoablation's role for benign fibroadenomas?
