IceCure Medical, Inc.

IceCure Medical manufactures the ProSense® Cryoablation System, a liquid-nitrogen-powered minimally invasive tumor ablation platform. The system uses ultra-low temperatures (below −170°C) to freeze and destroy benign and malignant tumors across multiple clinical applications. Primary indications include early-stage breast cancer in low-risk patients aged 70+ with tumors ≤1.5 cm (FDA-cleared for local treatment with endocrine therapy), kidney cancer, lung cancer, fibroadenomas, and palliative care applications. The ProSense system delivers rapid and stable freezing via a single cryoprobe inserted under ultrasound guidance, typically requiring 30–45 minute outpatient procedures under local anesthesia with minimal recovery time (median 1 day return to normal activity). Clinical evidence from the ICE3 trial demonstrates 3.1% local recurrence rate at 5 years in breast cancer patients treated with cryoablation plus endocrine therapy, with 99.1% patient and 97% physician satisfaction regarding cosmetic outcomes. The technology preserves tissue architecture, avoids general anesthesia and extended hospital stays, and maintains breast shape with minimal scarring. IceCure holds regulatory approvals globally, including FDA 510(k) clearance for breast cancer. The company operates a worldwide distributor network and provides comprehensive support for hospital and office-based practice integration.