News | Breast Imaging | March 14, 2025

Patients who underwent cryoablation compared to breast-conserving therapy reported significantly higher satisfaction in the primary outcome.


March 10, 2025 — IceCure Medical Ltd. has announced the publication of an independent study titled "Post-treatment patient satisfaction in early-stage breast cancer: Comparison of cryoablation versus breast conservation therapy using BREAST-Q" in the peer reviewed journal Gland Surgery.

IceCure Medical is a developer of minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal,

The study was conducted at the Breast Center, Kameda Medical Center in Kamogawa, Chiba, Japan by the co-authors of the article, Dr. Kizuki Matsumoto, Dr. Yuko Asano, Dr. Hiroki Matsui, and Dr. Eisuke Fukuma. A leading expert and breast surgeon, Dr. Eisuke Fukuma has performed over 600 ProSense breast cryoablation procedures, has presented on ProSense and has trained other doctors at medical conferences. 

In Japan, the de-escalation of treatment for breast cancer continues, with breast-conserving therapy ("BCT"), typically defined as standard of care breast surgery or lumpectomy, representing approximately 60% of all breast cancer cases, as novel nonsurgical options have emerged.

"In this study we aimed to evaluate and compare patient satisfaction after BCT and cryoablation. Assessing the patient's health-related quality of life ("HRQOL") holds significant clinical importance and studies examining long-term satisfaction following cryoablation, particularly in Asian patients, are limited," stated Dr. Kizuki Matsumoto. "Because of improved survival outcomes, breast cancer is becoming a chronic disease, making the survivor's quality of life and satisfaction a major focus of treatment. We were pleased with the outcome of the study and believe the use of cryoablation in breast cancer will be more widespread in the future."

IceCure's Chief Executive, Eyal Shamir commented, "We are grateful to the team at Kameda Medical Center for initiating this important study which focuses on women's satisfaction. The data clearly demonstrate that cryoablation resulted in greater quality of life and patient satisfaction than standard of care surgery in this early-stage breast cancer patient population. We believe these results will support our distribution partner, Terumo Corporation, in its application for regulatory approval of ProSense® for breast cancer in Japan."  

Study Highlights: 

  • A total of 147 Asian female breast cancer patients underwent cryoablation with ProSense® (n=42) or BCT (n=105). Among the 112 patients with stage 0 or 1 disease, 36 met the exclusion criteria and were excluded from the analysis. The remaining 76 (35 from the cryoablation group and 41 from the BCT group) were included in the analysis.
  • The study used the BREAST-Q questionnaire to assess patient HRQOL and satisfaction.
  • Patients who underwent cryoablation compared to BCT reported significantly higher satisfaction (71.0±18.6 vs. 56.3±16.5) in the primary outcome, with a mean follow-up of 4.2 and 4.0 years, respectively. This satisfaction trend was consistent across all the other measures.
  • The authors of the study indicate they believe patient satisfaction is higher with cryoablation of breast cancer as it does not involve excision, leaving breast volume and symmetry unchanged.

 


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