#Israel #Caesarea #IceCure Medical #Breast Cancer #ProSense

IceCure Medical Updates on FDA Timeline for ProSense® Cryoablation

IceCure Medical Ltd., a prominent player in the field of minimally-invasive cryoablation technology, has recently provided updates regarding its ongoing communications with the U.S. Food and Drug Administration (FDA). The company is pursuing marketing authorization for its ProSense® system, specifically designed for treating early-stage, low-risk breast cancer in conjunction with endocrine therapy. This innovative approach presents an alternative solution to surgical tumor removal, which is a critical concern considering the prevalence of breast cancer in public health.

The CEO of IceCure Medical, Eyal Shamir, expressed optimism during a recent statement, highlighting the importance of collaboration with the FDA as well as the involvement of numerous stakeholders in discussions surrounding the De Novo marketing authorization request. Given the uniqueness of their product offering, and the significant implications for women's health, the FDA has prioritized this matter.

As part of the regulatory process, the FDA has gathered a Medical Device Advisory Committee Panel, which convened in November 2024, to solicit independent expert advice on the safety and efficacy of ProSense®. This advisory panel included a diverse group of professionals—breast surgeons, interventional radiologists, breast oncologists, and community representatives—who collectively evaluated the risk-benefit profile of the ProSense® technology for its intended patient demographic. Encouragingly, the panel voted in favor of ProSense®, supporting its potential role in the management of early-stage, low-risk breast cancer.

The deadline for the FDA's decision is projected to fall post the first quarter of 2025. This timeline places IceCure Medical in a phase of anticipation and readiness, as they continue to prepare for potential market entry and subsequent distribution of their cryoablation system both in the United States and internationally. The ProSense® system has already seen successful applications in markets across Europe and Asia and aims to enhance treatment options, minimizing risk while effectively targeting tumors through cryotherapy.

Furthermore, the cryoablation treatment is characterized by its minimally invasive nature, which not only optimizes recovery time but also reduces patient discomfort compared to traditional surgical methods. IceCure’s ProSense® employs advanced liquid-nitrogen technology to safely freeze and destroy tumors, potentially offering a path toward wider acceptance and application in various oncological settings.

IceCure Medical's commitment to innovation is evidenced by its scientific research endeavors, which aim to create efficiencies in cancer treatment protocols. The company acknowledges the changing landscape of regulatory discussions and the complexities involved in bringing new medical devices to market, especially those addressing critical health issues like breast cancer.

In closing, as IceCure Medical looks forward to the FDA's decision regarding ProSense®, the company emphasizes its dedication to enhancing breast cancer treatment. Their proactive steps in regulatory dialogue and stakeholder engagement spotlight an aspiration to redefine how early-stage breast cancer is treated and managed. By potentially introducing ProSense® into clinical practice, IceCure hopes to facilitate a paradigm shift in patient care, thus setting a new standard for minimally invasive breast cancer therapies.