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IceCure Medical Reports Record 2025 ProSense® Sales Following Landmark FDA Breast Cancer Clearance

Story Highlights
  • In 2025 IceCure won FDA marketing authorization for ProSense®, the only on-label minimally invasive device for local treatment of low-risk breast cancer in U.S. women aged 70 and above.
  • Following the October 2025 clearance, IceCure achieved record global ProSense® sales of about $3.4 million, strong U.S. and European demand, expanded clinical evidence, new regulatory approvals, and a broader patent portfolio.
  • Looking for the best stocks to buy? Follow the recommendations of top-performing analysts.
IceCure Medical Reports Record 2025 ProSense® Sales Following Landmark FDA Breast Cancer Clearance

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Icecure Medical ( (ICCM) ) has issued an announcement.

On January 12, 2026, IceCure Medical reported that 2025 was a pivotal year marked by FDA marketing authorization in October 2025 for its ProSense® cryoablation system as the only on-label, minimally invasive device for the local treatment of low-risk breast cancer in women aged 70 and older with endocrine therapy, including non-surgical candidates, opening access to an estimated 200,000 U.S. patients annually. Following this clearance, the company experienced strong demand in the U.S. and record European sales, leading to preliminary record ProSense® sales of about $3.4 million and cash and cash equivalents of approximately $8.9 million for the year ended December 31, 2025, alongside record scientific visibility via independent peer-reviewed studies and conference presentations covering breast, musculoskeletal, kidney, lung cancers and endometriosis, as well as regulatory approvals in Switzerland and Israel and expansion of its patent portfolio, underscoring its strengthened commercial and clinical positioning in the global cryoablation market.

The most recent analyst rating on (ICCM) stock is a Hold with a $0.71 price target. To see the full list of analyst forecasts on Icecure Medical stock, see the ICCM Stock Forecast page.

Spark’s Take on ICCM Stock

According to Spark, TipRanks’ AI Analyst, ICCM is a Neutral.

Icecure Medical’s overall stock score is primarily impacted by its challenging financial performance, with persistent losses and negative cash flows. The technical analysis indicates a bearish trend, and valuation metrics are weak due to unprofitability. However, the positive sentiment from the earnings call, driven by FDA approval and strategic market opportunities, provides some optimism for future growth.

To see Spark’s full report on ICCM stock, click here.

More about Icecure Medical

IceCure Medical Ltd. is an Israel-based medical device company that develops and markets minimally invasive, liquid-nitrogen-based cryoablation systems for destroying benign and cancerous tumors, with primary focus on breast, kidney, bone and lung cancers. Its flagship ProSense® system, which offers a nonsurgical alternative for tumor removal and can be used in office-based procedures, is marketed and sold in the U.S., Europe and Asia for approved indications, and recently became the first and only device with FDA marketing authorization for the local treatment of low-risk breast cancer in women aged 70 and above with endocrine therapy, including those not suitable for surgery.

Average Trading Volume: 453,271

Technical Sentiment Signal: Sell

Current Market Cap: $48.22M

For detailed information about ICCM stock, go to TipRanks’ Stock Analysis page.

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