IceCure Reports Updated Timeline and Progress with FDA Regarding Marketing Authorization for ProSense® Cryoablation in Early-Stage Breast Cancer

Core Viewpoint - IceCure Medical is in discussions with the FDA regarding the De Novo marketing authorization for its ProSense® system, aimed at treating early-stage low-risk breast cancer with endocrine therapy, with a decision expected after Q1 2025 [1][2][3]. Group 1: FDA Collaboration and Advisory Panel - The FDA has involved multiple stakeholders in discussions about the ProSense® marketing clearance due to the product's novelty and the public health significance of breast cancer [2]. - An FDA Medical Device Advisory Committee Panel convened in November 2024 to provide independent advice on the potential marketing authorization of ProSense®, which included experts from various medical fields who voted in favor of its benefit-risk profile [4]. Group 2: Company Overview and Technology - IceCure Medical develops advanced cryoablation therapy systems that utilize liquid nitrogen to destroy tumors through freezing, focusing on breast, kidney, bone, and lung cancers [5]. - The ProSense® system is marketed globally and is positioned as a minimally invasive alternative to surgical tumor removal, allowing for relatively short procedures [5].