An investigation for investors in Surmodics, Inc. (NASDAQ:SRDX) shares over potential securities laws violations by Surmodics, Inc. was announced.
San Diego, CA -- (SBWIRE) -- 02/07/2023 -- An investigation was announced over potential securities laws violations by Surmodics, Inc. in connection with certain financial statements.
Investors who purchased shares of Surmodics, Inc. (NASDAQ: SRDX), have certain options and should contact the Shareholders Foundation at firstname.lastname@example.org or call +1(858) 779 - 1554.
The investigation by a law firm focuses on whether certain statements by Surmodics, Inc. regarding its business, its prospects and its operations were materially false and misleading at the time they were made.
Eden Prairie, MN based Surmodics, Inc., together with its subsidiaries, provides performance coating technologies for intravascular medical devices, and chemical and biological components for in vitro diagnostic immunoassay tests and microarrays in the United States and internationally. On January 19, 2023, Surmodics, Inc. announced it had received a letter from the U.S. Food and Drug Administration related to its premarket approval (PMA) application for the SurVeil™ drug-coated balloon (DCB). In the letter, the FDA indicated that the application is not currently approvable, while providing specific guidance as to a path forward. The letter stated that certain information within two general categories—biocompatibility and labeling—must be added by an amendment to the company's PMA application to place it in approvable form. Although the information identified by the Agency to put the PMA application in approvable form would require additional testing and analysis, the letter did not question the human clinical data submitted nor request any further human clinical data. Surmodic stated, "We are evaluating the issues raised in the FDA's letter and plan to meet with Agency representatives regarding its contents. Based on our discussion with the Agency, our team and external advisors will determine the appropriate path forward. Concurrently, we will be evaluating options to reduce our use of cash given this development."
Shares of Surmodics, Inc. (NASDAQ: SRDX) declined from $39.17 per share on January 10, 2023, to $24.33 per share on January 19, 2023.
Those who purchased shares of Surmodics, Inc. (NASDAQ: SRDX) have certain options and should contact the Shareholders Foundation.
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