IceCure Medical

ICCM

Market cap $45.9M

IceCure Medical Ltd (ICCM) Q4 2025 Earnings Call Transcript

Record 4th quarter and full year sales of $1.3 million and $3.4 million, respectively Strong commercial momentum for ProSense® in the U.S. and globally following FDA clearance in low-risk breast cancer and medical society recommendations 30 hybrid commercial-clinical sites to be added for FDA approved post-marketing study in addition to growing pipeline of potential commercial customers IceCure Applies to Expand Regulatory Approval in Canada for ProSense® Cryoablation to Include the Treatment of Low-Risk Breast Cancer  Conference call to be held today at 11:00 am Eastern Time CAESAREA, Israel, March 17, 2026 /PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure", "IceCure Medical" or the "Company"), developer of minimally-invasive cryoablation technology that destroys tumors by freezing as an option to surgical tumor removal, today reported record sales as of and for the twelve months ended December 31, 2025 as well as recent commercial and clinical updates.

IceCure is engaged with leading medical institutions throughout the U.S. looking to participate in the post-market study with the FDA-cleared ProSense® Clinical study sites may offer ProSense® cryoablation to additional patients not enrolled in the study, supporting its potential broader commercial adoption Post-market study will be conducted using cryoprobes sold exclusively by IceCure and facilities will be able to use CPT Category III reimbursement code CAESAREA, Israel, March 11, 2026 /PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure," "IceCure Medical" or the "Company"), developer of minimally-invasive cryoablation technology that destroys tumors by freezing as an option to surgical tumor removal, today announced that the U.S. Food and Drug Administration ("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 (the "Study").

CAESAREA, Israel, March 10, 2026 /PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure", "IceCure Medical" or the "Company"), developer of minimally-invasive cryoablation technology that destroys tumors by freezing as an option to surgical tumor removal, today announced that it will issue a press release with its financial and operational results as of and for the twelve months ended December 31, 2025 before the Nasdaq Stock Market opens on Tuesday, March 17, 2026.

IceCure's ICE3 study and the FDA Advisory Panel's favorable vote on ProSense® cryoablation's benefit-risk profile for low-risk breast cancer played a key role in the ASBrS 2026 Resource Guide update New medical society guidance expected to further accelerate commercial adoption of ProSense® following FDA-clearance for low-risk breast cancer in October 2025 CAESAREA, Israel, March 9, 2026 /PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure", "IceCure Medical" or the "Company"), a developer of minimally-invasive cryoablation technology that destroys tumors by freezing as an option to surgical tumor removal, today announced that the American Society of Breast Surgeons' ("ASBrS") updated 2026 "Resource Guide on the Use of Transcutaneous and Percutaneous Ablation for the Treatment of Benign and Malignant Tumors of the Breast" recommends cryoablation as an option for selected patients with biologically low-risk early-stage breast cancer.

Treatment with ProSense® resulted in 92.9% volume reduction of fibroadenoma one-year post-cryoablation Findings may impact treatment guidelines issued by medical societies for large non-cancerous breast tumors; study is believed to be the first to evaluate larger lesions and use multiple cryoprobe relocations ProSense® Cryoablation has FDA-clearance for fibroadenomas CAESAREA, Israel, March 2, 2026 /PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure", "IceCure Medical" or the "Company"), developer of minimally-invasive cryoablation technology that destroys tumors by freezing as an option to surgical tumor removal, today announced the publication of an independent, investigator-initiated study evaluating ProSense® for the treatment of non-cancerous breast tumors,  or fibroadenomas.

Previously released interim data from 111 patients demonstrated ProSense® is safe and effective in destruction of kidney tumors with 88.7% recurrence-free rate Incidence of kidney cancer is growing worldwide, with an estimated 400,000 new cases globally ; over 80,000 of which are in the U.S. alone hi ghlighting a growing unmet need ProSense® is approved for benign and malignant kidney tumors in the U.S., Europe, and numerous other countries CAESAREA, Israel, Feb. 23, 2026 /PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure," "IceCure Medical" or the "Company"), developer of minimally-invasive cryoablation technology that destroys tumors by freezing as an option to surgical tumor removal, today 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 ("SRMs") in kidney cancer patients.

First procedures to be performed in the coming weeks at Alabama's largest non-governmental healthcare system Purchase funded by the Thomas Foundation following FDA marketing authorization of ProSense® in low-risk breast cancer and inclusion of cryoablation in proposed medical society guidelines CAESAREA, Israel, Feb. 19, 2026 /PRNewswire/ -- IceCure Medical Ltd. (NASDAQ: ICCM) ("IceCure", "IceCure Medical" or the "Company"), a developer of minimally-invasive cryoablation technology that destroys tumors by freezing as an option to surgical tumor removal, today announced 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.

ProSense® system recently received FDA marketing authorization for the treatment of low-risk breast cancer Cryoablation for breast cancer is now included in proposed medical society guidelines for the approved patient population CAESAREA, Israel, Feb. 11, 2026 /PRNewswire/ -- IceCure Medical Ltd. (NASDAQ: ICCM) ("IceCure", "IceCure Medical" or the "Company"), a developer of minimally-invasive cryoablation technology that destroys tumors by freezing as an option to surgical tumor removal, today announced the most recent purchase and installation of the ProSense® system in the U.S. at St. Louis, Missouri based Shero Imaging, the first clinic in the state of Missouri to offer breast cancer cryoablation with ProSense®.

Ronen Tsimerman will continue as CFO until successor is appointed CAESAREA, Israel, Feb. 9, 2026 /PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure", "IceCure Medical" or the "Company"), a developer of minimally-invasive cryoablation technology that destroys tumors by freezing as an option to surgical tumor removal, today announced that after nearly a decade of service with IceCure, Chief Financial Officer Ronen Tsimerman has informed the Company of his decision to leave the Company to pursue new opportunities.