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
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