IceCure Medical Ltd. (ICCM) announced on Friday that the Advisory Panel of the U.S. Food and Drug Administration has given a favorable vote for the company's ProSense technology, designed for early-stage, low-risk invasive breast cancer.
This affirmative decision was based on data from IceCure's ICE3 study and was bolstered by testimonies and contributions from patients, researchers, medical professionals, and patient advisory groups.
The supporting panel members asserted that the benefits of ProSense technology, when utilized according to specified indications for the treatment of early-stage, low-risk invasive breast cancer with cryoablation and adjuvant endocrine therapy, outweigh any associated risks.
Following this panel vote, IceCure Medical anticipates an FDA decision by the first quarter of 2025. Currently, shares of IceCure are trading at $0.68 on the Nasdaq, experiencing a 6.93 percent decrease.
