IceCure ProSense Cryoablation Receives FDA Marketing Authorization for Treating Low-Risk Breast Cancer in Women Aged 70+ 

Oct. 3, 2025 — IceCure Medical Ltd., developer of minimally-invasive cryoablation technology that destroys tumors by freezing as an option to surgical tumor removal, recently announced that the U.S. Food and Drug Administration has granted marketing authorization to IceCure's De Novo application for the ProSense cryoablation system for the local treatment of breast cancer in patients ≥70 years of age with biologically low-risk tumors ≤1.5 cm in size and treated with adjuvant endocrine therapy, representing approximately 46,000 women annually in the U.S. The authorized indication includes patients that are not suitable for surgery for breast cancer treatment.  

"ProSense offers the first new innovation in the treatment of women aged 70 and above with low-risk early-stage breast cancer in decades. We are proud to deliver a significant advancement and enhancement to women's cancer care and quality of life," stated IceCure's chief executive officer, Eyal Shamir. 

"We expect that the FDA's marketing authorization, the very enthusiastic response from physicians who have had clinical experience with ProSense, and the existing reimbursement code, will all combine to drive strong demand for our cryoablation procedure in breast cancer. American women aged 70 and above diagnosed with low-risk, early-stage breast cancer now have access to a minimally invasive procedure that offers safe and effective treatment similar to standard of care lumpectomy, with excellent cosmetic results and patient satisfaction," Shamir added. 

Post-Market Study

In granting marketing authorization, the FDA requested that IceCure conduct a post-market surveillance study with the aim of producing additional data in this indication. The post-market study is expected to include approximately 400 patients at 30 sites, and the established reimbursement code may be used to support claims and reimbursement for the study procedures. These sites, while treating study participants, will also be active commercial sites where any appropriate patient seeking treatment with ProSense cryoablation may be treated.   

The FDA's marketing authorization also establishes that any other company wishing to file for 510(k) marketing authorization for a different cryoablation system to treat breast cancer will be required to submit five years of follow-up data. To IceCure's knowledge, no other company is currently conducting a breast cryoablation clinical study in the U.S.

"Our U.S. team has been diligently preparing for the FDA authorization, and we are ready to seize the opportunity to expand our U.S. customer base," stated VP of Sales North America, Shad Good. "While we expect the post-market study will support our product roll out through the initial 30 clinical sites, we are authorized to immediately commence ProSense sales and procedures, independent of the post-market study."

The FDA's marketing authorization was based on an abundance of data including IceCure's ICE3 trial, the largest multi-center clinical trial ever completed for liquid-nitrogen (LN2) based cryoablation for patients with low-risk, early-stage breast cancer without surgically removing the breast tumor.

ICE3 Investigator Richard Fine, MD, FACS, stated, "As proven in the ICE3 study, cryoablation with ProSense is a safe, minimally invasive ablative procedure with results similar to that of lumpectomy patients who took endocrine therapy, with the benefit of being an office-based, non-surgical treatment. Further data coming out of the post-market study should continue to support and confirm that cryoablation with ProSense is a successful alternative to surgical excision in appropriately selected patients."

Reimbursement Code Established

ProSense enhances patient, provider, and payor value by accelerating recovery, minimizing pain, surgical risks, and complications, all while minimizing the cost of treatment relative to standard of care lumpectomy. With its easy, transportable design and LN2 utilization, ProSense opens the door to fast and convenient out-patient procedures for breast tumors. 

ProSense has access to reimbursement under the CPT III code which covers $3,800 of facility costs. IceCure expects additional reimbursement coverage in the future based on the FDA's marketing authorization and other factors including the post market activity and recommendations from professional medical associations. 

Full Indication for ProSense

ProSense is authorized by the FDA for the local treatment of breast cancer in patients ≥70 years of age with biologically low-risk tumors ≤1.5 cm in size and treated with adjuvant endocrine therapy. Biologically low-risk breast cancer is defined as unifocal tumor, size ≤1.5cm, ER+, PR+, HER2-, Ki-67<15% and/or genomic testing indicative of low-risk breast cancer, infiltrating ductal carcinoma (excluding lobular carcinoma, extensive intraductal component, or evidence of lymphovascular invasion), and clinically negative lymph node (N0). The authorized indication includes patients that are not suitable for surgery for breast cancer treatment.

For a complete discussion of the benefits and risks of ProSense Cryoablation System for the local treatment of breast cancer, please visit the company's website.