Caesarea, Israel, October 20, 2026
IceCure Medical Ltd. has enrolled the first two patients in its U.S. post-marketing ChoICE Study, evaluating the ProSense® cryoablation system for the local treatment of eligible patients with low-risk breast cancer. The company announced that the first patient was enrolled at West Cancer Center & Research Institute in Germantown, Tennessee, while the second was enrolled at Adventist Health Glendale in California. The milestone marks the transition from clinical site preparation to active patient enrollment in a study designed to generate additional real-world evidence on minimally invasive breast cancer treatment. ProSense uses liquid-nitrogen-based cryoablation, a technique that destroys targeted tissue by freezing it, as an alternative to surgical tumor removal for appropriately selected patients. The ChoICE Study is expected to enroll approximately 400 patients across up to 30 clinical sites in the United States. The research will evaluate the device within its existing U.S. Food and Drug Administration (FDA)-cleared indication. According to IceCure, participating hospitals will serve as research centers and may also offer the treatment to eligible patients outside the study. The initiative is part of the company’s post-market evidence-generation strategy following regulatory clearance for a defined population with early-stage, biologically low-risk breast cancer.
ChoICE Study Begins Patient Enrollment at Two U.S. Sites
The initial enrollment milestone follows the establishment of participating clinical sites and the completion of required institutional review board approvals and site agreements. West Cancer Center & Research Institute enrolled the first participant under the direction of Dr. Richard E. Fine, director of the Margaret West Comprehensive Breast Center and lead author of the ICE3 study, which evaluated cryoablation for small, low-risk breast cancers. Adventist Health Glendale enrolled the second participant at its California facility, where breast surgeon Dr. Dennis Holmes leads the site. IceCure has continued expanding the study network, including the addition of Legacy Health’s Legacy Medical Group–Surgical Oncology at Good Samaritan Medical Center in Portland, Oregon. The planned multicenter study is intended to collect information about the use of ProSense in routine clinical practice and strengthen the available evidence for its approved indication. Post-marketing studies can help researchers and regulators understand device performance across clinical settings and gather further information about patient outcomes and treatment delivery. However, the first patient enrollments are a study milestone, not evidence of new clinical efficacy results. Outcomes will need to be assessed as more participants receive treatment and complete follow-up.
ProSense Uses Freezing Technology to Target Breast Tumors
The ProSense system uses a cryoprobe to deliver extremely cold temperatures to a targeted tumor, causing cellular injury and destruction through cryoablation. Unlike conventional surgery, which physically removes tissue, cryoablation aims to destroy the targeted tumor in place through controlled freezing. The approach is being evaluated as a less invasive local treatment option for a narrowly defined group of patients with early-stage breast cancer. In October 2025, the FDA cleared ProSense for the local treatment of patients aged 70 years and older with biologically low-risk breast tumors measuring 1.5 centimetres or less who receive adjuvant endocrine therapy. The cleared indication also includes patients who are not eligible for surgery. This specific eligibility criteria are important: the device is not intended to replace surgery for every breast cancer patient, and treatment suitability must be determined by the treating clinical team. Earlier evidence from IceCure’s ICE3 study contributed to the regulatory pathway for the device. The ChoICE Study is expected to add further real-world information within the approved population rather than establish a broader indication automatically. Patients should discuss the potential benefits, limitations and alternatives with their breast cancer specialists before making treatment decisions.
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Real-World Evidence May Inform Future Treatment Decisions
IceCure plans to enroll approximately 400 patients at as many as 30 U.S. sites, with the objective of generating additional clinical data on ProSense in real-world practice. The company expects the participating centers to support both study activities and commercial availability for eligible patients who are not enrolled in the research. This model could expand clinician experience with cryoablation while supporting the collection of follow-up information. The evidence may help healthcare professionals better understand how the technique is used in eligible patients, although the study’s design and collected data will determine which conclusions can be drawn. IceCure develops cryoablation systems for tumors in several organs, including the breast, kidney, bone and lung. Its ProSense platform is marketed internationally for indications cleared or approved in relevant jurisdictions. The ChoICE Study’s progress will depend on recruitment, follow-up and the quality of the resulting clinical data. The initial enrollments represent an important operational step, while further results will be required to clarify patient outcomes and the role of cryoablation in the management of low-risk breast cancer.
Source: IceCure Medical press release
