On March 20, 2025, IceCure Medical Ltd. announced an updated timeline for the U.S. Food and Drug Administration's (FDA) marketing authorization decision for its ProSense® system. The decision for early-stage low-risk breast cancer with endocrine therapy is now expected after the first quarter of 2025. This represents a delay from the previously anticipated Q1 2025 timeline.
IceCure stated that it is in continued discussions with the FDA, attributing the extended timeline to the novelty of the product and the public health importance of breast cancer. CEO Eyal Shamir acknowledged the FDA's attention despite an 'evolving situation' at the agency, as they work productively towards a decision on marketing authorization. The FDA had convened a Medical Device Advisory Committee Panel in November 2024, which voted in favor of ProSense®'s benefit-risk profile.
This delay impacts the company's commercialization timelines and financial projections for entering the significant U.S. market for this indication. Investors will be closely monitoring further updates regarding the FDA's review process and the new expected timeframe for a decision.
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