IceCure 2025 results: record Q4 sales on FDA clearance

IceCure Medical reports record sales following landmark FDA learance

Written by Heidi Cuthbert Published mar. 17 2026Last Updated mar. 17 2026

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IceCure Medical (NASDAQ:ICCM) announced record financial results for the fourth quarter and full year ended December 31, 2025, marking a transformative period for the Israeli medtech firm.

Fourth-quarter sales reached a record $1.3 million, contributing to a full-year revenue of $3.379 million.

This growth was primarily fueled by the company’s pivot to the U.S. market following the pivotal FDA clearance of ProSense®, a liquid nitrogen-based cryoablation system, for the treatment of low-risk, early-stage breast cancer.

The company’s clinical and regulatory successes have been bolstered by new guidelines from the American Society of Breast Surgeons (ASBrS), which now support the use of cryoablation as a viable alternative to traditional lumpectomy for select patients.

To further solidify this market position and drive physician adoption, IceCure has initiated the ChoICE study—a 30-site post-marketing registry designed to collect long-term data on local recurrence and patient satisfaction.

Patient enrollment for ChoICE is expected to commence in the second half of 2026.

Financially, the company is showing signs of improved operational efficiency.

IceCure reported a gross profit of $1.226 million for 2025, while its net loss narrowed to $15.057 million, down from the previous year as the company shifted from heavy R&D spending to commercial execution.

The balance sheet was also strengthened, with cash and cash equivalents rising to $8.897 million at year-end.

Beyond the U.S., IceCure is aggressively pursuing global expansion, with a pending regulatory application with Health Canada and ongoing commercial efforts in Europe and Asia.