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. 

promising ICE3 interim results

ICE3 Clinical Trial on Cryoablation of Low Risk, Small Breast Cancer interim results Presented at the 2021 Annual Meeting of the American Society of Breast Surgeons and published in the Annals of Surgical Oncology by Dr. Richard E. Fine.

PATIENTS

194

Eligible Patients for Cryoablation

19

Hospitals

(Including Columbia University Medical Center and Mount Sinai Beth Israel)

49

Patients Followed For 5 Years*

*By June 2021

RESULTS

97.94%

Recurrence Free as of April 2021

190 out of the 194 eligible patients did not have recurrence

 

100%

Safe Procedure

No significant device-related adverse events or complications have been reported

98%

Doctor Satisfaction
with Cosmetic Results

95%

Patient Satisfaction
with Cosmetic Results

No scarring or change to the shape and size of the breast

PROSENSETM ADVANTAGES

Clinically proven

Clinically proven

Cost effective in-office treatment

Short treatment time for fibroadenomas –
only 5-15 minutes

Touche Screen

Touch-screen console

ProSense Cryoablation System by IceCure Medical
Choice of probes

Choice of probes for
customized treatment

(small disposable
component)

Low pressure, safe, convenient and easy to use

Low pressure, safe,
convenient and easy to
use

Painless with immediate return to daily activities

Painless with immediate return to daily activities

FDA 510(k) cleared and CE marked

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