IceCure Medical is highlighting a study showing the potential of the company's ProSense cryoablation system, presented at the recent European Society of Breast Imaging annual meeting in Valencia, Spain.
ProSense is a minimally invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal, which may be useful in women deemed inoperable for breast cancer.
During the study, ultrasound-guided cryoablation using ProSense was performed on 28 women with a median age of 73.4 years. The women had biopsy-proven malignant lesions and were deemed inoperable. Of the total, 14 women were diagnosed with molecular subtype luminal-A tumors and the other 14 were diagnosed with luminal-B tumors. The women were monitored at one, three, and six months postprocedure, and tumor size reduction rate was evaluated by ultrasound.
The study authors reported the following size reduction rates:
- One month: 21.59% for luminal-A vs. 19.83% for luminal-B
- Three months: 70.16% for luminal-A vs. 60.71% for luminal-B
- Six months: 96.81% for luminal-A vs. 93.43% for luminal-B
The study also found that for the luminal-A group, there was an absence of residual malignant cells in all biopsy samples and a disappearance of lesions.
IceCure said the results validate similar results seen in the longer-term five-year post-procedure ICE3 study. The company said it expects that study to conclude in the first quarter of 2024.
![Examples of ultrasound findings and techniques. (A) Images in a 39-year-old male patient with a mass in the left thigh. The mass is heterogeneous on the B-mode US image (compared with the patient in D) and showed increased microvascularity (superb microvascular imaging [SMI]) and shear-wave elastography (SWE) values. Undifferentiated pleomorphic sarcoma was diagnosed at biopsy (with pleomorphic rhabdomyosarcoma in surgical specimen). (B) Images in an 18-year-old male patient with a mass in the left leg. The mass is hypoechoic on the B-mode image, with no other findings suggestive of malignancy. The lesion is in contact with the cortex of the tibia, which is slightly irregular. CT revealed a doubtful anteromedial tibial erosion. The microvascular study demonstrated high vascularization, suggestive of malignancy. Periosteal Ewing sarcoma was diagnosed with both histologic and immunohistochemical confirmation. (C) Images in a 69-year-old female patient with a lump growing on the outside of the left leg. Multiple SWE examinations were performed (please note the high values obtained in the measurements, whereas the color map highlights the stiffness relative to adjacent tissues). SMI showed areas of increased vascularization to target for sampling. Undifferentiated spindle cell sarcoma was diagnosed at biopsy, with residual leiomyosarcoma in the surgical specimen after neoadjuvant therapy. (D) Images in a 56-year-old female patient with a mass in the right thigh. The mass is heterogeneous at both B-mode ultrasound (similar to patient A) and MRI (coronal T2-weighted spectral attenuated inversion recovery [SPAIR]; T1-weighted pre-contrast and postcontrast imaging), which even shows uptake after the administration of paramagnetic contrast material, which is traditionally suggestive of malignancy. Low values at SMI and elastography are suggestive of benignity. Spindle cell lipoma was diagnosed at biopsy, with atypical spindle cell lipomatous tumor in the surgical specimen.](https://img.auntminnie.com/mindful/smg/workspaces/default/uploads/2026/08/images-radiol250278fig2.APCFLSvX6p.jpg?auto=format%2Ccompress&dpr=2&fit=crop&h=167&q=70&w=250)
