IceCure Medical Awaits FDA Decision on ProSense® for Breast Cancer

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IceCure Medical Awaits FDA Decision on ProSense® for Breast Cancer

Icecure Medical ( (ICCM) ) has provided an update.

On March 20, 2025, IceCure Medical announced ongoing discussions with the FDA regarding the De Novo marketing authorization for its ProSense® system in treating early-stage, low-risk breast cancer with endocrine therapy. The FDA’s decision is expected after the first quarter of 2025. The FDA convened an Advisory Panel in November 2024, which supported ProSense®’s benefit-risk profile. This development could significantly impact IceCure’s market position and stakeholder interests, given the public health importance of breast cancer.

More about Icecure Medical

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

YTD Price Performance: 20.33%

Average Trading Volume: 349,653

Technical Sentiment Consensus Rating: Hold

Current Market Cap: $83.16M

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

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