IceCure’s ProSense Evaluated for Treatment of Breast Cancer in Single-Center European Study

July 16, 2024—IceCure Medical Ltd. recently announced the publication of an independent, single-center study evaluating the company’s ProSense system for liquid nitrogen-based CT-guided percutaneous cryoablation treatment of breast cancer.

The study, which received no financial support from IceCure, was conducted at the Institute of Radiology and Nuclear Medicine, University Hospital Frankfurt, at Goethe University, in Frankfurt, Germany. Professor Thomas J. Vogl, MD, led the study as Principal Investigator. Prof. Vogl et al published the findings online in the European journal Cancers.

According to the company, the study investigators retrospectively evaluated the efficacy and safety of ProSense cryoablation. Patients were treated in outpatient settings with curative intention for nonmetastatic patients, while patients with metastases were treated to achieve local tumor control.

As summarized in IceCure’s press release, the patient population (n = 45, with 56 tumors) with a mean age of 55.6 ± 12.5 years (range, 31.3-86 years) and included 11 patients with recurrent tumors and 21 patients with metastatic disease. Patients were observed at 3, 6, 9, and 12 months. After the first year, they were followed up biannually.

The single-center study population was very heterogeneous and different from IceCure’s ICE3 study population, noted the company’s press release.

The investigators reported that there were four cases of local tumor progression, representing a rate of 8.9%. There were no complications observed in any of the 56 ablations and initial complete ablation was achieved in 100% of cases.

“Liquid nitrogen-based cryoablation was found to be a safe local treatment for breast cancer, with a low complication rate—in fact, none were observed in the study,” commented Prof. Vogl in IceCure’s press release. “We experienced a very high complete ablation rate of 100%. Overall survival, progression-free survival, and local tumor control were all good, especially given the very heterogenous patient population.”

Prof. Vogl continued, “The fact that this is a minimally invasive procedure that can be performed on an outpatient basis with excellent cosmetic results are clear advantages. We look forward to further evaluations of cryoablation especially in comparison to other treatment modalities for early, recurrent, and metastatic breast cancer.”

IceCure’s flagship ProSense system is marketed worldwide for those indications cleared and approved to date including in the United States, Europe, and China.

In September 2023, the company announced that the FDA denied the company’s de novo classification request for ProSense to treat breast cancer that was submitted based on interim analysis from its ICE3 study.

The company advised that the FDA’s position for breast cancer does not affect ProSense’s FDA clearance for other indications in the United States, where it has received clearance for general minimally invasive cryoablation applications, including kidney, liver, and benign breast tumors. ProSense is approved for the treatment of malignant breast tumors in other markets, including Europe, China, and Brazil, noted IceCure in the September 2023 press release.