IceCure Medical has enrolled the first two patients in its ChoICE study, which is evaluating the ProSense cryoablation system for the treatment of low-risk breast cancer. The patients were treated at two clinical centres in the USA.
ChoICE is a prospective, post-market trial that aims to enrol around 400 patients at up to 30 US centres. Its purpose is to collect real-world evidence within the indication that ProSense has already been cleared for by the US Food and Drug Administration (FDA).
Participating centres will act as both trial sites and commercial providers, meaning they can also offer ProSense cryoablation to eligible patients who are not part of the study cohort.
The first patient was enrolled at the West Cancer Center & Research Institute in Germantown, USA, under Richard Fine, director of the Margaret West Comprehensive Breast Center and lead author of the ICE3 study. The centre is examining cryoablation for small, low-risk breast tumours.
The second patient was enrolled at Adventist Health Glendale, USA, under breast surgeon Dennis Holmes. Both centres were cleared to begin recruiting in August 2026, once site contracts were executed and institutional review board approval was obtained.
IceCure has also recently added Legacy Medical Group, Surgical Oncology, part of Legacy Health, at Good Samaritan Medical Center in Portland, USA, to the ChoICE network.
“Enrolling the first patients marks continued progress in the execution of our post-market strategy for ProSense,” said Eyal Shamir, chief executive officer of IceCure Medical. “As we continue to expand the ChoICE study’s clinical network, we aim to generate additional real-world evidence while supporting broader clinical adoption and access to minimally invasive cryoablation for eligible patients.”
IceCure develops minimally invasive cryoablation systems that destroy tumours by freezing them rather than removing them surgically. According to the company, ProSense is the only device with FDA clearance for the local treatment of biologically low-risk breast tumours measuring 1.5cm or smaller in patients aged 70 and older who are receiving adjuvant endocrine therapy. This includes patients who are not eligible for surgery. The system is also marketed in Asia, Europe and the USA for its cleared indications.
In August, IceCure signed an exclusive distribution agreement with Scovas Medical for ProSense in the Netherlands.
