BACKED BY
CLINICAL EVIDENCE
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
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
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