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IceCure Medical Highlights Cryoablation Advantages for Breast Cancer

IceCure Medical Ltd., a trailblazer in minimally invasive cryoablation technology, has made headlines with the release of a peer-reviewed study in the prestigious International Journal of Surgery. This article sheds light on the clinical advantages of cryoablation over radiofrequency ablation (RFA) for early-stage breast cancer patients. As the company gears up for participation in the 34th Annual Meeting of the Japanese Breast Cancer Society in June 2026, this publication is particularly timely.

The International Journal of Surgery is recognized globally as one of the top surgical journals, holding a rank of third among its peers. Its reputation is built on the publication of high-quality clinical studies that significantly impact surgical practices worldwide. The recent article, titled "Thermal Ablation as a Minimally Invasive Alternative to Surgery for Primary Breast Cancer," was authored by renowned experts, Drs. Masato Takahashi, Takayuki Kinoshita, and Eisuke Fukuma from Japan. Professor Fukuma, noted for his expertise in cryoablation and his extensive experience with the ProSense® system, has executed approximately 680 cryoablation procedures for breast cancer.

The research highlights substantial clinical outcomes associated with cryoablation, which may provide a less invasive alternative to traditional surgical options for breast cancer treatment. It underscores that thermal ablation can achieve local tumor control rates comparable to breast-conserving surgery (BCS), especially for patients with smaller tumors. Moreover, this approach offers additional benefits, including shorter procedures, reduced scarring, and better aesthetic outcomes.

Key Findings of the Study

The article emphasizes several pivotal advantages of cryoablation when compared to RFA:

• - In a 2025 presentation at the JBCS Conference, Professor Fukuma reported an impressive recurrence-free rate of 99.02% among over 600 breast cancer patients treated with cryoablation, with follow-ups lasting up to 17 years. In contrast, the RAFAELO study on RFA indicated a 5-year ipsilateral breast tumor-free survival rate of 98.6% for 353 patients. Notably, after breast-conserving surgery (for invasive breast cancer stages I–II), standard practice in Japan usually involves radiation therapy.
• - Cryoablation can be administered under local anesthesia, providing greater comfort for patients compared to RFA, which necessitates general anesthesia.
• - The flexibility in adjusting the ice ball size during cryoablation, coupled with the visibility of its margin, enhances control during the procedure. In contrast, RFA faces challenges with tissue resistance, making control tricky due to inability to clearly visualize microbubbles.
• - Multiple studies reviewed within the article indicate no significant differences in local recurrence or overall survival rates between thermal ablation technologies (cryoadilation and RFA) and BCS in carefully selected patients with tumors measuring 2 cm or less.

The authors conclude by stating that "ultimately, thermal ablation holds promise as a beacon of hope for patients, offering surgeons a validated method to de-escalate treatment without compromising oncological safety while improving aesthetic outcomes compared to conventional BCS."

In a statement, Eyal Shamir, CEO of IceCure, expressed confidence in the growing body of evidence favoring cryoablation and its potential to gain traction among healthcare providers globally. He highlighted Japan as a crucial market for the ProSense® system, especially given the considerable amount of clinical research undertaken by prominent Japanese physicians.

IceCure anticipates that Terumo Corporation, its exclusive distributor in Japan and one of the country's largest medical device firms, will submit ProSense® for regulatory approval to Japan's Pharmaceuticals and Medical Devices Agency in the latter half of 2026. This submission will be supported by both international clinical evidence and local physician experiences with cryoablation technology.

About ProSense®

The ProSense® Cryoablation System is the first medical device to receive FDA marketing authorization for the local treatment of low-risk breast cancer in women aged 70 and above, particularly those not suitable for conventional surgical alternatives. This innovative system leverages liquid nitrogen to effectively destroy tumors through freezing. Its design not only accelerates recovery but also diminishes pain and surgical risks, making it an invaluable asset in cancer care. By enabling convenient office-based procedures, ProSense® seeks to expand patient access to minimally invasive treatment options, showcasing IceCure Medical's commitment to pioneering advancements in cancer treatment.

As this technology gains recognition, it's clear that the future of breast cancer treatment may be evolving beyond traditional surgical methods, opening new avenues for patient care.