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IceCure Medical Advances Toward FDA Approval for ProSense® in Breast Cancer Treatment

Story Highlights
  • IceCure Medical specializes in cryoablation therapy systems for tumor destruction.
  • IceCure is working with the FDA on a post-market study for ProSense® to treat breast cancer.
  • Looking for the best stocks to buy? Follow the recommendations of top-performing analysts.

The latest announcement is out from Icecure Medical ( (ICCM) ).

On April 30, 2025, IceCure Medical announced a significant development regarding its ProSense® Cryoablation System, following a meeting with the FDA’s Center for Devices and Radiological Health. The FDA has requested a post-market study for ProSense®, aimed at treating early-stage breast cancer in women aged 70 and over, which could lead to final marketing authorization. IceCure is preparing to submit its study plan and is engaging with clinical sites and professionals to support the study and drive market adoption. This development positions IceCure to potentially transform breast cancer treatment with a minimally invasive option, enhancing its market presence and offering a new choice for patients and healthcare providers.

Spark’s Take on ICCM Stock

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

Icecure Medical’s stock score reflects a company facing significant financial challenges, with ongoing losses and cash flow deficits. While there is positive momentum in product sales and potential future regulatory approvals, these are offset by increased expenses and delays in critical FDA decisions. The technical analysis shows mixed momentum indicators, and valuation remains a concern with a negative P/E ratio. Overall, the stock has both positive and negative outlooks, leading to a balanced score.

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

More about Icecure Medical

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

YTD Price Performance: -0.81%

Average Trading Volume: 303,869

Technical Sentiment Signal: Sell

Current Market Cap: $69.01M

See more insights into ICCM stock on TipRanks’ Stock Analysis page.

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