CAESAREA, Israel — IceCure Medical Ltd. (Nasdaq: ICCM), developer of the ProSense® System, a minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal, today 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-procedure, 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%
12 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 our minimally invasive procedure that takes up to 40 minutes. We are so pleased that women in this study, who were deemed inoperable, benefitted from cryoablation,” stated IceCure CEO Eyal Shamir. “We are working hard to get ProSense® approved, available and affordable for as many women as possible in a number of countries around the world. This independent study is further validation of our mission, and we thank Dr. di Naro for her initiative in leading the study and giving patients options that save and prolong lives.”
About ProSense®
The ProSense® Cryoablation System provides a minimally invasive treatment option to destroy tumors by freezing them. The system uniquely harnesses the power of liquid nitrogen to create large lethal zones for maximum efficacy in tumor destruction in benign and cancerous lesions, including breast, kidney, lung and liver.
ProSense® enhances patient and provider value by accelerating recovery, reducing pain, surgical risks and complications. With its easy, transportable design and liquid nitrogen utilization, ProSense® opens that door to fast and convenient office-based procedure for breast tumors.
About IceCure Medical
IceCure Medical (Nasdaq: ICCM) develops and markets ProSense®, an advanced liquid-nitrogen-based cryoablation therapy for the treatment of tumors (benign and cancerous) by freezing, with the primary focus areas being breast, kidney, bone and lung cancer. 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.
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