Caesarea, Israel, July 27, 2026
IceCure Medical Ltd. has announced the launch of its post-marketing ChoICE Study, with the West Cancer Center & Research Institute in Germantown, Tennessee becoming the first U.S. clinical site to evaluate the company’s ProSense® cryoablation system for the treatment of low-risk early-stage breast cancer. The study follows the U.S. Food and Drug Administration (FDA) marketing authorization granted to ProSense® in October 2025 and represents an important milestone in expanding access to minimally invasive breast cancer treatment. Designed to enroll up to 400 patients across 30 clinical sites in the United States, the ChoICE Study will generate valuable real-world clinical evidence supporting broader adoption of cryoablation as a non-surgical treatment option for eligible patients. The initiative also reflects IceCure Medical’s continued commitment to advancing evidence-based oncology care while improving treatment options for older women diagnosed with early-stage breast cancer.
ChoICE Study Expands Real-World Evidence for Cryoablation
The ChoICE Study is designed to evaluate the effectiveness of ProSense® cryoablation combined with adjuvant endocrine therapy in patients 70 years of age and older diagnosed with biologically low-risk, early-stage breast cancer. ProSense® is FDA-authorized for treating breast tumors measuring 1.5 centimeters or smaller in eligible patients, including those who may not be suitable candidates for surgery. Under the approved study design, participating hospitals and cancer centers will function both as clinical research sites and commercial treatment centers, allowing them to enroll study participants while also providing ProSense® cryoablation to eligible patients outside the formal study. This dual-access model is expected to accelerate physician experience, increase patient access to minimally invasive treatment, and generate meaningful post-marketing evidence that can support wider clinical adoption across the United States.
West Cancer Center Becomes First U.S. Clinical Site
The West Cancer Center & Research Institute, recognized for its comprehensive oncology programs and extensive clinical research expertise, will lead the first U.S. implementation of the ChoICE Study. The study at the center will be directed by Dr. Richard Gilmore, a breast surgical oncologist at the Margaret West Comprehensive Breast Center. IceCure believes that collaboration with leading oncology institutions will strengthen physician confidence in cryoablation technology while expanding real-world experience with ProSense®. According to the company, every new clinical site joining the ChoICE Study will contribute valuable patient data that can further validate the safety, effectiveness, and practical application of cryoablation as an alternative to conventional breast cancer surgery. The study also supports growing patient demand for less invasive procedures that preserve quality of life while delivering effective local tumor control.
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IceCure Advances Minimally Invasive Breast Cancer Innovation
The launch of the ChoICE Study reinforces IceCure Medical’s strategy of expanding the clinical evidence supporting liquid nitrogen-based cryoablation technology across multiple oncology indications. The company’s flagship ProSense® system is already marketed internationally for several approved indications involving breast, kidney, bone, and lung tumors, offering physicians a minimally invasive alternative to traditional surgical tumor removal. By focusing on post-marketing evidence generation following FDA authorization, IceCure aims to demonstrate the long-term clinical value of cryoablation while supporting broader reimbursement, physician adoption, and patient access. As additional U.S. clinical sites begin enrolling participants, the ChoICE Study is expected to provide robust real-world insights into the role of ProSense® in managing low-risk breast cancer, potentially helping shape future treatment pathways for older patients seeking effective, tissue-preserving cancer therapies.
Source: IceCure Medical press release
