The ProSense® Cryoablation System:
A new hope in breast care
ProSense® is a liquid nitrogen (LN2) based cryoablation system with a powerful, compact, and user-friendly design for maximum efficacy in breast tumor destruction.
IceCure’s ProSense Cryoablation System utilizes liquid nitrogen to generate ultra-cold temperatures quickly to create large lethal zones for maximum efficacy in tumor destruction.
Guided by CT or ultrasound, a cryoprobe is inserted into the tumor. A freeze-thaw-freeze cycle destroys the targeted tissue, which becomes necrotic debris eventually absorbed by the body over time – without the need to excise the tumor.
Cost effective in-office treatment
Short treatment time for fibroadenomas –
only 5-15 minutes
Choice of probes for
Low pressure, safe,
convenient and easy to
Painless with immediate return to daily activities
and CE marked
ICE3 is the largest controlled multilocation clinical trial ever performed for liquid nitrogen (LN2) – based cryoablation of small, low-risk, early-stage malignant breast tumors without subsequently removing them. The trial began in 2014 and has completed recruitment of 206 patients in 19 hospitals and medical centers across the US, including Columbia University Medical Center and Mount Sinai Beth Israel.
promising ICE3 interim results
Based on interim analysis performed in July 2022
Eligible Patients for Cryoablation
(Including Columbia University Medical Center and Mount Sinai Beth Israel)
Patients Followed For 5 Years*
*As of July 2022
Recurrence Free as of July 2022
188 out of the 194 eligible patients did not have recurrence
No significant device-related adverse events or complications have been reported
with Cosmetic Results
with Cosmetic Results
No scarring or change to the shape and size of the breast
The ProSense™ system is considered an optimal solution for treating breast tumors.
ProSense is FDA-cleared and has successfully been treating fibroadenomas since clinical trials began in 2012.
“The FDA has approved the use of cryoablation as a safe and effective therapy for fibroadenomas.”
American Society of Breast Surgeon’s (ASBrS) Consensus Statement for Management of Fibroadenomas of the Breast
ICE3 is the largest controlled multilocation clinical trial ever performed for nitrogen-based cryoablation of small, low-risk, early stage malignant breast tumors without subsequently removing them.
of trial participants did not have recurrence as of interim analysis performed in July 2022.
“Cryoablation offers an exciting, minimally invasive option to open surgery in the treatment of small, early-stage breast cancer tumors. The innovative Liquid Nitrogen (LN2) based ProSense® System provides more efficient, targeted treatment to completely destroy the tumor in a quick, office-based procedure”
Professor Eisuke Fukuma, MD, PhD, Chairman of Breast Center, Kameda Medical Center, Japan