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PR Newswire
Tue, March 17, 2026 at 8:30 AM EDT 18 min read
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
, /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.
Three significant events are expected to drive commercial adoption of ProSense®:
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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. The updated guidance represents an important step toward broader clinical adoption of IceCure's ProSense® cryoablation system.
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The U.S. Food and Drug Administration ("FDA") approved the study design for IceCure's post-marketing study for ProSense® in the treatment of low-risk breast cancer. Patient enrollment for the "ChoICE" study is expected to commence by the second half of 2026, with at least 80 patients enrolled in the first year of the study. The ChoICE study is expected to enroll and treat 400 patients within 36 months across 30 clinical sites in the U.S. which can be used commercially.
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On March 16, 2026, the Company submitted a Class III amendment application to Health Canada seeking to expand its current regulatory approval to include the use of the ProSense® cryoablation system for the treatment of early-stage, low-risk invasive breast cancer in patients aged 60 years and older. The application is supported by data from IceCure's ICE3 clinical study, the largest study of its kind, which served as the basis for the FDA's marketing clearance of ProSense® in the treatment of low-risk breast cancer. Under the proposed indication in Canada, up to 7,130 number of women would be eligible for breast cancer cryoablation. A decision is expected during the second half of 2026, subject to the agency's standard review procedures and potential follow-up questions.
