IceCure Medical Ltd. (ICCM), Friday announced that the U.S. Food and Drug Administration's Advisory panel has voted in favor of the company's ProSense technology intended for early-stage low risk invasive breast cancer.
The favorable vote relied on data from the company's ICE3 study, as well as testimonies and input from patients, researchers, doctors, nurses and patient advisory groups.
The panel members, who voted in favor, claimed that ProSense technology outweighs risks when used according to the indications for the treatment of early-stage low risk invasive breast cancer patients with cryoablation and adjuvant endocrine therapy.
Based on the panel's vote, the company expects FDA decision in the first quarter of 2025.
Currently, IceCure's stock is trading at $0.68, down 6.93 percent on the Nasdaq.
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