IceCure Medical (ICCM) said Thursday it expects a US Food and Drug Administration decision regarding its De Novo marketing authorization request for ProSense as a potential treatment for early-stage low-risk breast cancer with endocrine therapy after Q1.
The company said it remains in continued discussions with the FDA regarding the request.
"Given the novelty of our product and the importance of breast cancer in public health, the FDA has included many stakeholders in the discussion," said IceCure Chief Executive Eyal Shamir.
Shares of the company were down more than 17% in recent premarket activity.
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