ProSense Cryoablation Reviews Reinforce Breast Cancer De-Escalation Role

Two new peer-reviewed publications by leading US clinicians that reinforce the expanding clinical role of cryoablation in breast cancer treatment de-escalation.¹ One review cites the FDA marketing authorization of the company's ProSense® cryoablation system, its inclusion in updated American Society of Breast Surgeons (ASBrS) guidelines, and encouraging outcomes from the 5-year ICE3 clinical trial (NCT02200705), while a second publication extends the clinical discussion of cryoablation to axillary lymph node metastases.

ProSense®, a liquid nitrogen–based system that destroys tumors by freezing, received FDA marketing authorization in October 2025 for use in patients 70 years and older with biologically low-risk breast tumors 1.5 cm or smaller who are treated with adjuvant endocrine therapy.² IceCure, the manufacturer, has positioned the device as a minimally invasive breast-conserving alternative within the broader shift toward de-escalated breast cancer care.

Review Cites FDA Authorization and ICE3 Outcomes

The first article, a review titled "Cryoablation within the Evolving Paradigm of Multidisciplinary Breast Cancer Treatment De-Escalation,”³ examines the clinical evidence, procedural considerations, and place of breast cryoablation within the broader move toward less burdensome treatment approaches with safety and effectiveness outcomes similar to surgical options. The review highlights ProSense®'s authorized use in selected early-stage, low-risk breast cancers in patients 70 years and older, as well as ongoing studies including IceCure's ChoICE postmarketing trial.

Among the evidence cited is the 5-year follow-up of the ICE3 trial, a single-arm, multicenter study of cryoablation without surgical excision in women with early-stage, low-risk breast cancer, which the review reports produced a 3.1% ipsilateral breast tumor recurrence (IBTR) rate.⁴

Second Publication Addresses Axillary Nodal Disease

The second article, "Cryoablation of Axillary Lymph Node Metastases for the Curative and Palliative Treatment of Breast Cancer”⁵ provides practical guidance on cryoablation of axillary lymph node metastases in patients who are poor surgical candidates or decline surgery. The authors report that cryoablation can be performed safely, with high technical success and low complication rates, in both curative and palliative settings, expanding the clinical discussion of cryoablation beyond the primary tumor to regional nodal disease.

"These peer-reviewed publications by leading clinicians reflect the medical community's growing recognition of cryoablation as a meaningful option within breast cancer treatment de-escalation strategies. We believe the expanding body of peer-reviewed literature and clinical evidence will significantly support our commercialization efforts and the broader adoption of ProSense® worldwide,” said Eyal Shamir, chief executive officer, IceCure Medical, in a news release.¹

About ProSense®

ProSense® is IceCure Medical's flagship liquid nitrogen–based cryoablation system, developed to destroy benign and cancerous tumors by freezing as an option to surgical removal. The device is marketed for breast, kidney, bone, and lung indications cleared or approved in the United States, Europe, and Asia. Following its October 2025 FDA marketing authorization, IceCure launched the ChoICE postmarketing study, which is expected to enroll up to 400 patients across 30 US clinical sites to generate additional real-world data on ProSense® in low-risk breast cancer.

REFERENCES

1. IceCure Highlights Two New Peer-Reviewed Publications Supporting Cryoablation in Breast Cancer Treatment De-Escalation. News release. IceCure Medical Ltd. August 13, 2026. Accessed August 21, 2026. https://tinyurl.com/4ukcjam6

2. U.S. FDA Approves IceCure's Post-Marketing "ChoICE" Study for ProSense® Cryoablation in the Local Treatment of Low-Risk Breast Cancer. News release. IceCure Medical Ltd. March 11, 2026. Accessed August 21, 2026. https://tinyurl.com/4yxdkxyu

3. Yao AL, Ward RC, Dibble EH. Cryoablation Within the Evolving Paradigm of Multidisciplinary Breast Cancer Treatment De-Escalation. Clin Breast Cancer. 2026;26(9):84-90. doi:10.1016/j.clbc.2026.07.021

4. Fine RE, Gilmore RC, Tomkovich KR, et al. Cryoablation Without Excision for Early-Stage Breast Cancer: ICE3 Trial 5-Year Follow-Up on Ipsilateral Breast Tumor Recurrence. Ann Surg Oncol. 2024;31(11):7273-7283. doi:10.1245/s10434-024-16181-0

5. Huang ML, Lane DL, Amini B, Chang Sen LQ, Candelaria RP, Santiago L. Cryoablation of Axillary Lymph Node Metastases for the Curative and Palliative Treatment of Breast Cancer. J Breast Imaging. 2026. doi:10.1093/jbi/wbag023