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IceCure Medical’s ProSense® Receives FDA Approval for Breast Cancer Treatment

Story Highlights
  • IceCure Medical’s ProSense® system gains FDA approval for treating low-risk breast cancer.
  • FDA authorization expected to boost demand and set a new standard in breast cancer care.
  • Looking for the best stocks to buy? Follow the recommendations of top-performing analysts.
IceCure Medical’s ProSense® Receives FDA Approval for Breast Cancer Treatment

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An update from Icecure Medical ( (ICCM) ) is now available.

On October 3, 2025, IceCure Medical announced that its ProSense® cryoablation system received FDA marketing authorization for treating low-risk breast cancer in women aged 70 and above. This authorization marks a significant advancement in minimally invasive cancer treatment, offering a new option to lumpectomy with excellent cosmetic results and patient satisfaction. The FDA’s decision is expected to drive demand for the procedure, supported by existing reimbursement codes and a planned post-market study involving 400 patients across 30 sites. The study aims to gather additional data and support the commercial rollout of ProSense®, potentially setting a new standard of care for the defined indication.

The most recent analyst rating on (ICCM) stock is a Hold with a $1.00 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 significant financial challenges, including declining revenues and substantial losses. While there is optimism around regulatory progress and clinical achievements, these are overshadowed by weak financial performance and valuation concerns.

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

More about Icecure Medical

IceCure Medical, a company listed on Nasdaq as ICCM, specializes in advanced cryoablation therapy systems using liquid nitrogen to destroy tumors. The company’s primary focus areas include breast, kidney, bone, and lung cancer. Their flagship product, the ProSense® system, is marketed globally for various approved indications, offering a minimally invasive alternative to surgical tumor removal.

Average Trading Volume: 1,794,861

Technical Sentiment Signal: Sell

Current Market Cap: $67.49M

Learn more about ICCM stock on TipRanks’ Stock Analysis page.

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