ICCM News & Events

IceCure Medical announced that the FDA has approved the study design for the "ChoICE Trial Post-Market Study," the Company's post-marketing study for ProSense in the treatment of low-risk breast cancer. Patient enrollment is expected to commence in the second half of 2026, with at least 80 patients expected to be enrolled in the first year of the Study. The FDA previously granted marketing authorization in October 2025 for ProSense for the treatment of patients aged 70 years and older with biologically low-risk tumors less than or equal to1.5 cm in size who are treated with adjuvant endocrine therapy. In connection with its grant of marketing authorization, the FDA requested that IceCure conduct a post-market surveillance study to generate additional real-world data regarding the use of ProSense in this indication. The Study is expected to enroll and treat approximately 400 patients across 30 clinical sites in the U.S. within 36 months. IceCure has already received interest and engagement from leading medical institutions across the country seeking to participate in the Study. Under the approved study design, participating sites will treat enrolled patients while also serving as active commercial sites, providing cryoablation to patients outside of the study, thereby supporting the Company's commercial expansion. The Study will be conducted using cryoprobes sold exclusively by IceCure and facilities will be able to use an established CPT Category III reimbursement code. Study procedures are eligible for reimbursement under the established Centers for Medicaid and Medicare Services CPT Category III code, which provides approximately $4,000 for the facility fee alone.

IceCure Medical announced the completion of its last patients' five-year follow up evaluation in its ICESECRET clinical trial of ProSense for the treatment of small renal masses in kidney cancer patients. ICESECRET, a prospective, multicenter, single-arm clinical trial, included 114 patients with localized SRMs of less than or equal to 5 cm ablated with ProSense cryoablation under CT guidance. Safety was determined by monitoring procedure-related adverse events throughout the study. ProSense is approved for benign and malignant kidney tumors in the U.S., Europe, and other countries

IceCure Medical announced that after nearly a decade of service with IceCure, CFO Ronen Tsimerman has informed the company of his decision to leave the company to pursue new opportunities. The company has initiated a search for a new CFO and has identified compelling candidates with significant experience commercializing disruptive technologies. Some candidates have recently advanced in the selection process to interviews with IceCure's Board of Directors. Tsimerman will continue in his role until a successor is appointed, to ensure a smooth transition.

A letter from CEO Eyal Shamir to shareholders stated, in part, "2025 was a pivotal year for IceCure - we were granted the U.S. Food and Drug Administration's marketing authorization for ProSense cryoablation for the local treatment of low-risk breast cancer with endocrine therapy in women aged 70 and above, including those who are not candidates for breast cancer surgery. This achievement has strengthened our belief that ProSense can expand patient choice, enhance care, and offer improved healthcare economics through a minimally invasive approach. This milestone marks a meaningful step toward establishing cryoablation as a new standard of care for eligible women in the United States seeking effective care without surgical removal of breast tissue. Following the FDA marketing authorization in October 2025, we have experienced and continue to experience an overwhelmingly positive response and interest in ProSense consoles and disposable cryoprobes. This has contributed to record fourth quarter results in 2025 in North America. We are particularly enthused to see systems being placed at highly regarded institutions in the United States, which we believe can further accelerate broader adoption of ProSense. Our sales team is engaged with leading hospitals, clinics, breast surgeons, and interventional radiologists currently evaluating ProSense in the U.S. Based on preliminary, unaudited estimates, IceCure delivered a record ProSense sales of approximately $3.4 million for the year ended December 31, 2025, driven by growing demand in the U.S. and record sales in Europe as we continue to execute our global commercial strategy. Our cash and cash equivalents balance as of December 31, 2025 was approximately $8.9 million. This preliminary financial information has been prepared solely on the basis of information that is currently available to, and that is the responsibility of, management. This preliminary financial information is based upon our estimates and remains subject to, among other things, the completion of IceCure's financial closing procedures and final adjustments, which may impact the results and expectations set forth above. We also saw continued advancement in the large body of data supporting ProSense for other indications. In 2025, independent investigators produced a record number of peer-reviewed publications and presentations regarding the use of ProSense for breast, musculoskeletal, and kidney cancers. We believe this expanding body of evidence is critical to long-term adoption and to supporting expanded clinical use around the world."