IceCure Medical Ltd. announced new data from a preliminary, independent breast cancer study conducted by Principal Investigator and ProSense®? user, Dr. Federica. di Naro, of Azienda Ospedaliero-Universitaria Careggi, Diagnostic Senology Unit in Florence, Italy.

IceCure previously announced interim results from this study on October 5, 2023. ProSense®? is approved in Italy for numerous indications, including breast cancer.

In the single-site study conducted between January 2022 and January 2024, ultrasound-guided cryoablation using ProSense®? was performed on 39 women aged 60-92, who had biopsy-proven malignant lesions, and were deemed inoperable due to advanced age and comorbidities, or who refused surgery. Patients were monitored at 1, 3, 6 and 12 months post-procedure, at which time the tumor size reduction rate was evaluated by ultrasound.

Also at 12 months post-procedures, the effectiveness of the procedure was further evaluated by core needle biopsy on the post-procedural scar (inside the breast at the site of the tumor) and contrast enhanced mammography ("CEM") to determine the presence or absence of residual tumoral cells and effectiveness of cryoablation. The median breast cancer tumor size reduction rates reported in the study were as follows: 1 month: 27.8% 3 months: 60.9% 6 months: 100.0% " These are phenomenal results of 100% median tumor size reduction in as little as 6 months and its effectiveness demonstrated by correlation between CEM outcomes versus biopsy at 12 months after minimally invasive procedure that takes up to 40 minutes. Its minimally invasive technology is a safe and effective alternative to hospital surgical tumor removal that is easily performed in a relatively short procedure.

The system is marketed and sold worldwide for the indications cleared and approved to date including in the U.S., Europe and China.