IceCure’s ProSense Cryoablation Therapy Studied in Japan to Treat Early-Stage Breast Cancer Tumors

May 7, 2024—IceCure Medical Ltd. announced the publication of data from an independent study performed in Japan of the company’s ProSense system. ProSense is a minimally invasive, liquid nitrogen-based cryoablation therapy for the treatment of benign and cancerous tumors.

The study focused on the local control of cancer, safety, patient quality of life, patient satisfaction, and cosmetic outcomes of cryoablation for patients with early-stage breast cancer. Hisanori Kawamoto, MD, who led the study, is from the Department of Breast Surgery, Breast and Imaging Center at St. Marianna University School of Medicine in Kawasaki, Japan. The findings by Dr. Kawamoto et al are available online in Breast Cancer.

As summarized in the IceCure press release, 18 patients (mean age, 59 ± 9 years) with early-term breast cancer (mean tumor size, 9.8 ± 2.3 mm) who underwent treatment with ProSense were followed for a mean term of 44.3 months. The investigators reported that no patients had local recurrence or distant metastasis in the 5-year follow-up. No serious adverse events were reported. Cosmetic outcomes were excellent and the overall patient satisfaction level and patient quality of life improved post-cryoablation.

“This is a very important study in Japan, where we are experiencing an upward trend in breast cancer cases, especially among women in their late 40s to early 60s,” commented Dr. Kawamoto. “These are women who often are at very active stages of their life and therefore there is a growing demand for treatment options that minimize the chance of or avoid hospitalization, in addition to resulting in favorable clinical and cosmetic outcomes. We are very pleased with these results and are hopeful that ProSense may become a favored option in Japan upon regulatory approval for early-stage breast cancer.”

IceCure advised that the study is a continuation of a pilot study that demonstrated percutaneous cryoablation treated with ProSense is a potential standard treatment for early-stage breast cancer patients, given compliance to predefined patient selection criteria. In November 2021, the company announced the publication of the pilot study findings by Dr. Kawamoto et al in the Journal of Cancer Therapy (2021;12:563-576).

Terumo Corporation owns the exclusive distribution rights for ProSense in Japan for a 5-year term after regulatory approval, advised IceCure in the press release.