FDA Updates Decision on ProSense Cryoablation for Early-Stage Breast Cancer

US FDA

• The FDA has extended the review period for its De Novo marketing authorization request for the ProSense cryoablation system.
• The FDA's decision regarding the authorization of ProSense for the treatment of early-stage, low-risk breast cancer with endocrine therapy is now expected to be reached after the first quarter of 2025.
• This delay comes as the FDA continues its discussions with IceCure Medical, indicating ongoing evaluation of this novel technology.
  

The FDA extended the review period for its De Novo marketing authorization request for the ProSense cryoablation system, and a decision regarding the authorization of ProSense for the treatment of early-stage, low-risk breast cancer with endocrine therapy is now expected to be reached after the first quarter of 2025.¹

This update comes from the continued discussions between the FDA and IceCure Medical, signifying an ongoing and thorough evaluation of this innovative technology.

"Given the novelty of our product and the importance of breast cancer in public health, the FDA has included many stakeholders in the discussion of the De Novo marketing clearance for ProSense® for the treatment of early-stage, low-risk breast cancer with endocrine therapy," stated Eyal Shamir, chief executive officer of IceCure, in a press release.

3D rendering of breast cancer: © Giovanni Cancemi - stock.adobe.com

ProSense is a minimally invasive cryoablation technology that destroys tumors by freezing. The ProSense cryoablation system presents a potential alternative to surgical tumor removal. It utilizes liquid nitrogen to create precise freezing zones, thereby minimizing damage to surrounding healthy tissue.

The FDA's review process has included the convening of a Medical Device Advisory Committee Panel in November 2024, where experts in breast surgery, interventional radiology, breast oncology, and patient advocacy provided input on the benefit-risk profile of ProSense. Notably, the advisory panel voted favorably on ProSense's benefit-risk profile in early-stage low risk breast cancer.

The FDA's evaluation is also supported by data from the ICE3 trial, a multi-center study assessing ProSense in patients with early-stage, low-risk breast cancer.² Interim data from this trial have demonstrated promising results concerning recurrence-free survival and safety. As of July 2022, the recurrence-free survival was 96.91%, as 188 of 194 eligible patients did not have a cancer recurrence.³

ICE3 is the largest controlled, multi-location trial of liquid-nitrogen-based cryoablation, and is evaluating ProSense in malignant breast tumors that are small, low-risk, and early-stage.² The trial followed 82 patients with breast cancer for 5 years. A total of 194 patients were eligible for cryoablation across 19 hospitals in the US, including Columbia University Medical Center and Mount Sinai Beth Israel.

Additional findings from ICE3 showed that the procedure was 100% safe.³ No significant divide-related adverse events or complications were reported, and there was no scarring or change to the shape or size of the breast.

"We appreciate the attention of many at the FDA despite the evolving situation at the agency as we work productively together towards a decision on marketing authorization," Shamir added in the press release.

REFERENCES:

1. IceCure reports updated timeline and progress with FDA regarding marketing authorization for ProSense® cryoablation in early-stage breast cancer. News release. IceCure Medical Ltd. March 20, 2025. Accessed March 20, 2025. https://tinyurl.com/6328x55u

2. The ICE3 trial - cryoablation of small, low-risk breast cancer. IceCure. Accessed March 20, 2025. https://www.icecure-medical.com/resources/ice3-trial/

3. U.S. FDA grants IceCure medical's appeal: reopens de novo classification request for marketing authorization of ProSense® for early-stage breast cancer. News release. IceCure Medical Ltd. January 30, 2024. Accessed March 20, 2025. http://tinyurl.com/bddafwn2