Surmodics, Inc

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Portnoy Law Firm
Lesley F. Portnoy, Esq.,
Office: 310.692.8883
1800 Century Park East, Suite 600
Los Angeles, CA 90067

The investigation is looking into whether Surmodics, the company, made false and/or misleading statements and/or failed to disclose important information to its investors. On January 19, 2023, the company announced that it had received a letter from the FDA stating that the approval for their drug-coated balloon (DCB) product, SurVeil™, could not be approved in its current form and that additional information on biocompatibility and labeling must be provided before approval. In response to the FDA letter, the company stated that they are evaluating the issues raised and plan to meet with the FDA to determine the next steps. They also mentioned that they will be evaluating options to reduce their use of cash due to this development. As a result of this news, the company’s shares fell by over 28.3%.