NEW YORK, March 09, 2023 (GLOBE NEWSWIRE) —

WHY: Rosen Law Firm, a global investor rights law firm, continues to investigate potential securities claims on behalf of shareholders of Surmodics Inc. SRDX based on allegations that Surmodics may have disclosed materially misleading business information to the investing public.

SO WHAT: If you have purchased Surmodics securities, you may be entitled to compensation without payment of out-of-pocket expenses or costs through a contingency fee arrangement. Law firm Rosen is preparing a class action lawsuit to recover investor losses.

WHAT TO DO NEXT: To participate in the prospective class action lawsuit, go to https://rosenlegal.com/submit-form/?case_id=11326 or call Phillip Kim, Esq. toll free at 866-767-3653 or by email pkim@rosenlegal.com or cases@rosenlegal.com for information about the Class Action.

WHAT IS THIS ABOUT: On January 19, 2023, Surmodics announced that it had received a letter from the U.S. Food and Drug Administration related to its Premarket Marketing Authorization (PMA) application for the SurVeilTM Drug Coated Balloon (DCB). In the letter, the FDA pointed out that the application is currently not eligible for approval and at the same time gave specific instructions on how to proceed. The letter states that certain information within two broad categories — biocompatibility and labeling — must be added through an amendment to the company’s PMA application in order to place it in an approvable form. Although the information identified by the Agency would require additional testing and analysis to bring the PMA application into an approvable form, the letter did not question the human clinical data submitted, nor did it request additional human clinical data. Surmodics stated, “We are reviewing the issues raised in the FDA’s letter and plan to meet with agency officials regarding the content. Based on our discussions with the agency, our team and external consultants will determine the appropriate way forward. At the same time, we will be evaluating options to reduce our cash consumption in the face of these…