IceCure's ProSense Cryoablation Expands in U.S. With New Study Approval and Alabama Installation

IceCure Medical Ltd. (NASDAQ: ICCM) announced that the Institutional Review Board (JHM-IRB) of West Cancer Center & Research Institute in Germantown, Tennessee, has granted approval for the Company's post-marketing ChoICE Study for ProSense® cryoablation in the local treatment of low-risk breast cancer. The approval advances the study and enables patient enrollment, which is expected in the coming weeks. ProSense® is the first and only medical device to be granted U.S. Food and Drug Administration (FDA) marketing authorization for the local treatment of low-risk breast cancer with endocrine therapy in women aged 70 and above.

The ChoICE Study will evaluate ProSense® cryoablation with endocrine therapy for low-risk, early-stage breast cancer in patients aged 70 years and older. ProSense® is cleared by the FDA for the local treatment of breast cancer in patients aged 70 years and older with biologically low-risk tumors ≤1.5 cm in size who are treated with adjuvant endocrine therapy, including patients who are not eligible for surgery. The study aims to generate additional real-world data regarding the use of ProSense® in this indication.

Under the approved study design, 30 participating sites will serve both as ChoICE Study centers and as active commercial sites, enabling them to enroll a total of 400 patients while also offering ProSense® cryoablation to appropriate patients who are not participating in the ChoICE Study. This dual pathway expands access to breast cancer cryoablation and reflects increasing interest from eligible patients seeking a minimally invasive alternative outside the trial setting. The site will be led by a breast surgical oncologist at the Margaret West Comprehensive Breast Center, part of West Cancer Center & Research Institute.

The successful results from the Company's ICE3 clinical trial demonstrated that ProSense® cryoablation followed by endocrine therapy achieved a 3.1% rate of local recurrence in women with early-stage, low-risk breast cancer. 99.1% of patients and 97% of physicians that responded to a survey reported high rates of satisfaction with the cosmetic outcomes. These results supported the FDA's marketing authorization for ProSense® in appropriately selected patients aged 70 years and above.

In a separate development, IceCure announced that Thomas Hospital of Fairhope, Alabama, part of the Infirmary Health network of hospitals, purchased and installed the ProSense® system, becoming the first facility in Alabama to offer breast cancer cryoablation. First procedures are scheduled to commence this month, with a board-certified breast surgeon and Medical Director of Breast Surgical Services at Thomas Hospital selecting patients. The hospital's purchase was made possible by the Thomas Hospital Foundation, a nonprofit organization dedicated to supporting Thomas Hospital to access state-of-the-art medical technology.

IceCure Medical develops and markets advanced liquid-nitrogen-based cryoablation therapy systems for the destruction of tumors (benign and cancerous) by freezing, with the primary focus areas being breast, kidney, bone and lung cancer. Its minimally invasive technology is a safe and effective option to surgical tumor removal that is easily performed in a relatively short procedure. The Company's flagship ProSense® system is marketed and sold worldwide for the indications cleared and approved to date including in the U.S., Europe, and Asia.