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The ICE3 Trial – Cryoablation of Low Risk Breast Cancer

We are dedicated to providing reliable clinical support for the ProSense™ System, so that physicians and other stakeholders can adopt our technology with confidence as the gold standard in tumor therapy.

ICE3

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 interim results

Presented at the 2021 Annual Meeting of The American Society of Breast Surgeons 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

Read the full ASBrS Press Release: “Freezing Cancer: Cryoablation Emerging as an Effective Treatment of Low Risk Breast Cancers – Three-year results of the ICE3 Trials”

“Cryoablation potentially represents a dramatic improvement in care for appropriate low-risk patients, and at three years post-treatment, the ICE3 trial results are extremely positive. The noninvasive procedure is fast, painless and can be delivered under local anesthesia in a doctor’s office. Recovery time is minimal and cosmetic outcomes are excellent with little loss of breast tissue and no scarring. Now, this trial is underscoring the efficacy and safety of the procedure for this patient group.”

Richard E. Fine, MD, FACS, Director of Education and Research and practicing breast surgeon at West Cancer Center’s Comprehensive Breast Center, TN and ICE3 Investigator

AVAILABILITY

ProSense™ is commercially available in the US, Europe, Hong Kong, Thailand, Singapore, Central America and South America.

Contact us for details