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# IceCure Medical Appeals De Novo Denial
- URL: https://www.fdaweb.com/icecure-medical-appeals-de-novo-denial/
- Published: 2023-11-15T12:00:00.000Z
- Updated: 2026-09-14T14:16:13.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5155799

Israel’s IceCure Medical says it is appealing FDA’s denial of the company’s *de novo* classification request for its ProSense system to treat patients with early-stage, low-risk breast cancer. A company [statement](https://www.prnewswire.com/il/news-releases/icecure-medical-files-appeal-with-us-fda-requesting-a-review-of-its-de-novo-classification-for-prosense-in-early-stage-breast-cancer-301989039.html?ref=fdaweb.com) says the ProSense is a minimally invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal. IceCure says it filed the *de novo* request in 10/2022 based on interim data from the ICE3 breast cancer study for the breakthrough indication of early-stage low-risk breast cancer patients. It says the interim results estimate a five-year 95.7% recurrence-free rate and 100% patient and doctor satisfaction with cosmetic results.

FDA notified IceCure on 9/20 that it had denied the request. The company says it believes the decision is largely due to the agency’s choice of comparator group against which the ICE3 results were evaluated. IceCure says it will use the appeal to work with FDA to identify a comparator group that is more representative of the patient group it is seeking to treat with the ProSense system. Under FDA guidelines IceCure says it expects to receive an agency response by the end of 1/2024.

The statement says the *de novo* denial does not affect ProSense’s FDA-cleared authorization for other indications.