IceCure names first ChoICE Study site after FDA-cleared breast cancer use

Adventist Health Glendale can begin enrolling patients after signing its agreement and receiving IRB approval for the post-marketing ProSense® study in low-risk breast cancer.

Summary

IceCure Medical said Adventist Health Glendale in California has become the first clinical site able to enroll patients in the post-marketing ChoICE Study for ProSense® after completing its site agreement and receiving Institutional Review Board approval. The study follows U.S. Food and Drug Administration authorization granted in October 2025 for local treatment of low-risk breast cancer with ProSense® in certain patients aged 70 and older. The ChoICE Study is designed to enroll up to 400 patients across 30 U.S. sites and collect real-world data on ProSense® cryoablation (tumor destruction by freezing) used with endocrine therapy. IceCure said participating centers will operate both as study locations and active commercial sites, allowing them to treat trial participants while also offering the therapy to appropriate patients outside the study. The company said this structure is intended to broaden access and support further clinical adoption. Adventist Health Glendale's site will be led by Dr. Dennis Holmes, MD, FACS, whom the company described as a breast surgeon and recognized authority in breast cancer cryoablation. IceCure Chief Executive Officer Eyal Shamir said the hospital adds breast care expertise and clinical infrastructure as the company works to expand real-world use of ProSense® across leading U.S. sites. Dr. Holmes said cryoablation may offer a less invasive option for carefully selected older patients with low-risk, early-stage breast cancer and that the study will further assess its use in routine practice, including follow-up and adherence to endocrine therapy. IceCure, based in Caesarea, Israel and listed on Nasdaq under ICCM, develops liquid-nitrogen-based cryoablation systems for breast, kidney, bone and lung tumors. Its flagship ProSense® system is marketed in the U.S., Europe and Asia for cleared and approved indications.

Terms & Concepts
  • cryoablation: Tumor destruction by freezing tissue.
  • Institutional Review Board: Ethics committee overseeing human research.
  • endocrine therapy: Hormone-blocking treatment used in some cancers.