FDA Authorizes IceCure’s ProSense Cryoablation for Early Stage Breast Cancer

October 9, 2025—IceCure Medical Ltd. announced that the FDA has granted marketing authorization for its ProSense cryoablation system for the local treatment of early-stage, biologically low-risk breast cancer in women ages ≥ 70 years—including patients who are not suitable for surgical alternatives for breast cancer treatment—when combined with adjuvant endocrine therapy.

The FDA has requested that the company conduct a postmarket surveillance study composed of approximately 400 patients at 30 United States sites to further evaluate long-term outcomes, advised IceCure.

According to the company, the ProSense system uses liquid nitrogen to freeze and destroy tumor tissue as a minimally invasive alternative to lumpectomy.

The FDA authorization was supported by data that included results from the multicenter ICE3 trial of liquid-nitrogen–based cryoablation in breast cancer. ICE3 enrolled 194 patients age ≥ 60 years with low-risk, early-stage breast cancer.

As summarized in IceCure’s press release, the ICE3 results showed a 3.1% local recurrence rate at 5 years among hormone receptor-positive, HER2-negative breast cancer patients treated with cryoablation plus endocrine therapy. Most adverse events, including edema, bruising, hematoma, and mild pain, resolved without sequelae.

The results were published by Richard E. Fine, MD, et al in Annals of Surgical Oncology (2024;31:7273–7283).

“The ICE3 study has proven that cryoablation with ProSense is a safe, minimally invasive ablative procedure with results similar to that of lumpectomy patients who took endocrine therapy and has the benefit of being an office-based, nonsurgical treatment,” commented Dr. Fine in IceCure’s press release. “Further data coming out of the postmarket study should continue to support that cryoablation with ProSense is a successful option in the de-escalation of breast cancer care in appropriately selected patients.”