Surmodics, Inc.

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Before the market opened on January 19, 2023, Surmodics announced receipt of a letter from the U.S. Food & Drug Administration (FDA), indicating that the Company’s pre-market approval application for its Surveil drug-coated balloon is not currently approvable. The FDA letter noted the need for additional information regarding biocompatibility and labeling.

Shares of Surmodics, Inc. stock dropped more than 25% in intraday trading on January 19, 2023.

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