IceCure Medical Ltd. reported that its flagship ProSense cryoablation system generated record sales of $3.4 million for the year ended December 31, 2025, a 6.8% increase from the $3.19 million recorded in 2024. The growth was driven by strong demand in the United States and Europe, with U.S. sales accounting for the majority of the increase following the device’s recent FDA marketing authorization.
The FDA approval, granted in October 2025 for the local treatment of low‑risk breast cancer in women aged 70 and above, positioned ProSense as the only on‑label minimally invasive option in the U.S. market. The approval accelerated U.S. adoption, contributing to the 6.8% YoY sales rise and reinforcing the company’s competitive advantage in a niche indication that had previously lacked a minimally invasive solution.
IceCure’s cash balance stood at $8.9 million as of December 31, 2025. The balance reflects a rights offering that began on July 10, 2025, aimed at raising up to $10 million, and a $2 million bridge loan from Epoch Partner Investments Limited received on May 17, 2025. These financing actions helped shore up liquidity amid ongoing net losses, which totaled $15.32 million for 2024, and supported the company’s ability to invest in further product development and market expansion.
Despite the record sales, profitability remained a challenge. Gross margin for 2024 was 44%, and the company continued to post net losses, underscoring the need for continued cost discipline and scale to achieve profitability. The FDA approval is expected to drive future revenue growth, but the company must also manage the costs associated with expanding its U.S. footprint and developing next‑generation systems.
CEO Eyal Shamir described 2025 as a “pivotal year” for IceCure, citing the FDA approval and the strong market response in the U.S. as key drivers of the company’s progress. He emphasized the company’s focus on building a robust commercial strategy and expanding its global presence while maintaining a disciplined approach to capital allocation.
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