IceCure Medical

IceCure Medical

Founded in 2006 and headquartered in Caesarea, Israel, IceCure Medical Ltd. operates as a publicly traded medical-device company (Nasdaq: ICCM) specializing in minimally invasive cryoablation. Its core technology, the ProSense system, uses liquid nitrogen to freeze and destroy benign and malignant tumors — including early-stage breast cancer — without requiring surgery. The company received its first FDA clearance for general minimally invasive cryoablation in 2013, followed by a specific breakthrough device designation for early-stage breast cancer treatment. IceCure's commercial model generates revenue from both the capital sale of its ProSense consoles and the single-use disposable cryoprobes that accompany each procedure. The system targets a broad oncology market spanning breast cancer, kidney tumors, liver metastases, and lung lesions across multiple geographies, including the United States (via direct sales and a distribution partner), Asia (through Terumo Corporation and other regional distributors), and Europe. Clinical coverage includes the landmark ICE3 trial, whose final results — presented in 2023 — reported a 96.39% local recurrence-free rate for early-stage breast cancer patients treated with ProSense, supporting the company's FDA submission for a breast-cancer specific indication. As of early 2025, IceCure operates a lean facility in Israel and maintains a manufacturing site in Shoham. In February 2024, the company submitted the final ICE3 clinical module to the FDA, seeking a specific indication for T1 invasive breast cancer — the event that will determine whether ProSense graduates from a general-use tool to an accredited first-line oncology therapy in the US. The firm reports routine commercial sales across 19 countries, with a growing installed base in both hospital radiology departments and independent outpatient imaging centers. Structurally, IceCure competes as a single-device platform company in a tier dominated by larger imaging and surgical robotics players. Its differentiation rests on a self-contained cryoablation system that uses liquid nitrogen rather than argon gas — a design choice that eliminates the need for expensive gas-cylinder infrastructure and enables portability, an advantage in outpatient settings and markets outside major hospital networks. The company remains pre-profit, funding operations through a combination of product revenue, public-market equity raises, and distribution partnerships with medical-device multinationals.