NEW YORK, March 14, 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. (NASDAQ: SRDX) resulting from allegations that Surmodics may have issued materially misleading business information to the investing public.

SO WHAT: If you purchased Surmodics securities you may be entitled to compensation without payment of any out of pocket fees or costs through a contingency fee arrangement. The Rosen Law Firm is preparing a class action seeking recovery of investor losses.

WHAT TO DO NEXT: To join the prospective class action, go to https://rosenlegal.com/submit-form/?case_id=11326 or call Phillip Kim, Esq. toll-free at 866-767-3653 or email [email protected] or [email protected] for information on the class action.

WHAT IS THIS ABOUT: On January 19, 2023, Surmodics announced it had received a letter from the U.S. Food and Drug Administration related to its premarket approval (PMA) application for the SurVeilTM 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. Surmodics 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.”

On this news, Surmodics’ share price fell $10.57, or 28%, to close at $26.77 per share on January 19, 2023.

WHY ROSEN LAW: We encourage investors to select qualified counsel with a track record of success in leadership roles. Often, firms issuing notices do not have comparable experience, resources, or any meaningful peer recognition. Many of these firms do not actually litigate securities class actions. Be wise in selecting counsel. The Rosen Law Firm represents investors throughout the globe, concentrating its practice in securities class actions and shareholder derivative litigation. Rosen Law Firm has achieved the largest ever securities class action settlement against a Chinese Company. Rosen Law Firm was Ranked No. 1 by ISS Securities Class Action Services for number of securities class action settlements in 2017. The firm has been ranked in the top 4 each year since 2013 and has recovered hundreds of millions of dollars for investors. In 2019 alone the firm secured over $438 million for investors. In 2020, founding partner Laurence Rosen was named by law360 as a Titan of Plaintiffs’ Bar. Many of the firm’s attorneys have been recognized by Lawdragon and Super Lawyers.

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Contact Information:

        Laurence Rosen, Esq.
        Phillip Kim, Esq.
        The Rosen Law Firm, P.A.
        275 Madison Avenue, 40th Floor
        New York, NY 10016
        Tel: (212) 686-1060
        Toll Free: (866) 767-3653
        Fax: (212) 202-3827
        [email protected]
        [email protected]
        [email protected]
        www.rosenlegal.com