On March 25, 2026 IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure", "IceCure Medical" or the "Company"), developer of minimally-invasive cryoablation technology that destroys tumors by freezing as an option to surgical tumor removal, reported positive top-line results from its ICESECRET clinical trial of ProSense for the treatment of small renal masses ("SRMs") in kidney cancer patients.
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A total of 114 patients were enrolled in the study, of whom 112 were evaluated at a median follow-up of four years (IQR 1.4–5.3). The study demonstrated that 83.9% of patients were recurrence-free at this median follow-up period. Among these patients, 12 underwent a second cryoablation procedure at a mean of 1.73±1.2 years. In a subgroup of patients with tumors ≤3 cm, no prior kidney cancer, and successful initial procedures, the recurrence-free rate reached 89.4%.
More detailed data from the study will be presented by Principal Investigator Prof. Halahmi Sarel at the European Conference on Interventional Oncology ("ECIO"), which will take place form April 26 to 30, 2026, in Basel, Switzerland.
ProSense is currently approved in the U.S., Europe and other key markets for the treatment of malignant and benign kidney tumors.
"We believe the positive top-line results from this study further reinforce cryoablation with ProSense as an effective and durable treatment option for patients with small renal masses," said Eyal Shamir, Chief Executive Officer of IceCure. "We believe these findings may help drive broader commercial adoption of ProSense in countries where it is already approved to treat kidney tumors, as physicians and healthcare systems continue to seek minimally invasive alternatives with strong long-term outcomes."
ICESECRET, a prospective, multicenter, single-arm clinical trial, was performed at Bnai Zion Medical Center in Haifa, Israel and Shamir Medical Center in Be’er Ya’akov, Israel and is led by Principal Investigator Prof. Halahmi Sarel. The trial included 114 patients (138 lesions) with localized SRMs of ≤5 cm ablated with ProSense cryoablation under CT guidance. Follow-up visits were performed at six weeks, six months, one year and then annually up to five years after the procedure using ProSense. During follow-up visits, data related to local recurrence, based on CT imaging, was collected. Safety was determined by monitoring procedure-related adverse events throughout the study.
SRMs are increasingly detected due to increased imaging and represent a growing clinical challenge, particularly among elderly patients and those with comorbidities who are not suitable candidates for surgery. Minimally invasive, nephron-sparing treatment options that preserve kidney function, while effectively controlling tumors, are critically needed. The incidence of kidney cancer is growing worldwide, with an estimated 400,000 new of kidney cancer cases globally, according to a 2024 study published in Nephrology Dialysis Transplantation. As of 2025, over 80,000 new cases of kidney cancer are diagnosed in the U.S. alone, according to the U.S. National Cancer Institute, highlighting a growing, unmet need.
About ProSense
The ProSense Cryoablation System is the first and only medical device to receive FDA marketing authorization for the local treatment of low-risk breast cancer with adjuvant endocrine therapy for women aged 70 and above, including patients who are not suitable for surgical alternatives for breast cancer treatment. A full list of benefits and risks can be found on the Company’s website.
ProSense is a minimally invasive cryosurgical tool that provides the option to destroy tumors by freezing them. The system uniquely harnesses the power of liquid nitrogen to create large lethal zones for maximum efficacy in tumor destruction in benign and cancerous lesions, including in the breast, kidney, lung, and liver.
ProSense enhances patient and provider value by accelerating recovery, reducing pain, surgical risks, and complications. With its easy, transportable design and liquid nitrogen utilization, ProSense opens the door to fast and convenient office-based procedures for breast tumors.
(Press release, IceCure Medical, MAR 25, 2026, View Source [SID1234663915])