IceCure Medical · raw details

IceCure is transforming healthcare with the choice of advanced minimally invasive cryoablation for benign and malignant tumors in women's health and interventional oncology. The FDA cleared and CE marked ProSense® System uses liquid-nitrogen (LN2) to generate ultra cold temperatures to destroy tumors by freezing them and is supported by clinical experience across multiple areas of cancer care.

Unlike surgical removal of a tumor, cryoablation is less invasive as only a thin, needle-like cryoprobe is placed into the tumor, no tissue is removed, and it is performed under local anesthesia or light sedation. Under imaging guidance (ultrasound or CT), LN2 enters the close-looped cryoprobe needle and a lethal ice ball forms around the targeted tissue. The destroyed tissue undergoes a necrotic process, to naturally remove the ablated cells over time, without needing to surgically remove it.

IceCure led the ICE3 clinical trial on cryoablation of early-stage, low-risk breast cancer, one of the largest studies of its kind. The ICE3 demonstrated a 96.3% recurrence-free rate for early-stage, low-risk breast cancer patients who underwent ProSense cryoablation with endocrine therapy. Patients and physicians reported a high level of satisfaction with the cosmetic results, as only a small nick is made in the skin to insert the cryoprobe and the breast remains whole. An FDA panel voted favorably on ProSense's benefit-risk profile in November 2024.

The ICESECRET study interim results for the destruction of kidney tumors has shown IceCure's ProSense® cryoablation system to be safe and effective in the destruction of kidney tumors with 88.7% recurrence-free rate.

ProSense® currently has FDA clearance for use as a cryosurgical tool in the destruction of fibroadenomas and in the fields of general surgery, thoracic surgery, gynecology, oncology, proctology, and urology. The system is CE-marked and is available across several European and East Asian countries, Brazil, and India.