Cryoablation System Delivers Positive Topline Results in Kidney Cancer

Top-line findings from the ICESECRET clinical trial (NCT02399124) featuring the ProSense Cryoablation System for the treatment of small renal masses (SRMs) in kidney cancer patients demonstrated that after a median follow-up of 4 years (IQR, 1.4-5.3) among 112 evaluable patients, 83.9% were recurrence-free.

The trial included 114 patients (138 lesions) with localized SRMs of 5 cm or smaller ablated with ProSense cryoablation under CT guidance. Follow-up visits were performed at 6 weeks, 6 months, 1 year and then annually up to 5 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.¹

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 professor Halahmi Sarel.

The trial sought to create an ice ball that surrounds the whole tumor with 5 mm margins using the ProSense Cryoablation System, as observed under laparoscopic, ultrasound or CT imaging during the procedure

According to the manufacturer, IceCure Medical, Ltd, more detailed data from the study will be presented by professor Halahmi Sarel at the European Conference on Interventional Oncology, which will take place form April 26 to 30, 2026, in Basel, Switzerland.

The ProSense system is currently approved in the US, 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,” Eyal Shamir, chief executive officer of IceCure, said in a release. “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.”

SRMs

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.

ProSense Cryoablation System

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.²

Biologically low-risk breast cancer is defined as unifocal tumor, size 1.5 cm and smaller, ER-positive, PR-positive, HER2-negative, Ki-67 less than15% and/or genomic testing indicative of low-risk breast cancer, infiltrating ductal carcinoma (excluding lobular carcinoma, extensive intraductal component, or evidence of lymphovascular invasion), and clinically negative lymph node (N0). The authorized indication includes patients that are not suitable for surgery for breast cancer treatment.

REFERENCES

1. IceCure Reports Positive 5-Year Top-Line Results from ICESECRET Kidney Cancer Cryoablation Study: 89.4% and 83.9% Recurrence-Free Rates. News release. March 25, 2026. Accessed March 26, 2026. https://tinyurl.com/38npbwv8

2. IceCure Medical's ProSense® Cryoablation Granted FDA Marketing Authorization for Treatment of Low-Risk Breast Cancer in Women Aged 70 and Above: Significant Development in Giving Women with Breast Cancer Minimally Invasive Care. News release. October 3, 2025. Accessed March 26, 2026. https://tinyurl.com/mumkfsua