IceCure Medical’s ProSense Cryoablation System Receives the US FDA Marketing Authorization for Breast Cancer

Shots:

• The US FDA granted De Novo marketing authorization to ProSense cryoablation system for treating women (≥70yrs.) with biologically low-risk breast tumors (≤1.5cm) on adjuvant endocrine therapy
• ProSense is a minimally invasive cryosurgical tool that uses liquid nitrogen to freeze & destroy tumors in breast, kidney, lung & liver, with similar safety & efficacy observed in the ICE3 trial for low-risk breast cancer compared to lumpectomy
• Additionally, FDA requested IceCure to conduct a post-market surveillance study of ~400 pts across 30 sites, which will also serve as commercial centers offering ProSense cryoablation to eligible breast cancer pts

Ref: PRNewsWire | Image: IceCure Medical| Press Release

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