IceCure Medical Appeals with US FDA for a Review of its De Novo Classification for ProSense in Early-Stage Breast Cancer
Portfolio Pulse from Benzinga Newsdesk
IceCure Medical Ltd. has filed an appeal with the FDA for a review of its De Novo Classification Request for ProSense, a cryoablation technology for treating early-stage breast cancer, after the initial denial.
November 15, 2023 | 12:36 pm
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NEUTRAL IMPACT
IceCure Medical has appealed the FDA's denial of its De Novo Classification for ProSense, which could impact the company's ability to market the product in the U.S.
The appeal represents a significant step for IceCure Medical in its efforts to bring ProSense to the U.S. market. However, the outcome of the appeal is uncertain, and until a decision is made, the impact on the stock price is likely to be neutral. The importance is high due to the potential market opportunity for ProSense, but the confidence in the impact is moderated by the unpredictability of regulatory decisions.
CONFIDENCE 75
IMPORTANCE 90
RELEVANCE 80