ProSense® is a liquid nitrogen (LN2) based cryoablation system with a powerful, compact, and user-friendly design for maximum efficacy in breast tumor destruction.
promising ICE3 interim results
Based on interim analysis performed in July 2022
PATIENTS
194
Eligible Patients for Cryoablation
19
Hospitals
(Including Columbia University Medical Center and Mount Sinai Beth Israel)
82
Patients Followed For 5 Years*
*As of July 2022
RESULTS
96.91%
Recurrence Free as of July 2022
188 out of the 194 eligible patients did not have recurrence
100%
Safe Procedure
No significant device-related adverse events or complications have been reported
100%
Doctor Satisfaction
with Cosmetic Results
100%
Patient Satisfaction
with Cosmetic Results
No scarring or change to the shape and size of the breast
PROSENSETM ADVANTAGES
Clinically proven
Cost effective in-office treatment
Short treatment time for fibroadenomas –
only 5-15 minutes
Touch-screen console
Choice of probes for
customized treatment
(small disposable
component)
Low pressure, safe,
convenient and easy to
use
Painless with immediate return to daily activities
FDA cleared
and CE marked
CLINICAL SUPPORT
The ProSense™ system is considered an optimal solution for treating breast tumors.
Fibroadenomas
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 Trial
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.
97.94%
of trial participants did not have recurrence as of April 2021.
Interim results presented at the 2021 Annual ASBrS Meeting by Dr. Richard E. Fine, MD
“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
Watch the ICE3 Study Update at ASBrS 2021
This 2021 ASBrS exhibitor learning session was moderated by ICE3 investigator Dr. Richard E. Fine who discussed the ICE3 Clinical Trial on Cryoablation in Small, Low-Risk Breast Cancer Interim Results.
Case studies were provided by fellow ICE3 Investigators Dr. Susan A. Seedman and Dr. Michael Berry.
In this webinar you will learn about:
- Overview of the ProSense® Liquid Nitrogen Cryoablation System
- ICE3 Interim Results on the Cryoablation of Small Low-Risk, Breast Cancer as presented at ASBrS 2021
- Two ICE3 trial case studies
- Question and Answer Session