IceCure Medical is a small Israeli medical device company that makes cryoablation systems — devices that destroy tumors by freezing rather than surgically removing them. IceCure's flagship product is the ProSense system, which uses liquid nitrogen to freeze and kill tumors in a minimally invasive outpatient procedure lasting 15 to 40 minutes. A thin probe is inserted through a small incision, guided by ultrasound or CT imaging, and liquid nitrogen circulates through the probe to form an ice ball that destroys the tumor; the dead tissue is then absorbed naturally by the body. IceCure's primary focus is breast tumors — both malignant breast cancer and benign fibroadenomas — with secondary applications in lungs, kidneys, bones, and endometriosis. In October 2025, ProSense received FDA marketing authorization for treating biologically low-risk breast cancer in women aged 70 and above, making it the first and only device cleared in the U.S. specifically for malignant breast cancer. IceCure sells directly to hospitals, interventional radiology centers, ambulatory surgery centers, and private clinics in the U.S. and Japan, and through distributors elsewhere. IceCure follows a razor/razor-blade model: ProSense consoles are sold or placed at clinical sites, and recurring revenue comes from the single-use disposable probes required for each procedure. Reimbursement is a key gating factor for U.S. adoption; a CPT Category III code currently covers roughly $4,000 in facility fees per procedure, and IceCure plans to apply for a permanent CPT Category I code by June 2026 to also cover physician fees. IceCure is pre-profitability with approximately $3M in annual revenue.
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