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 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. 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.”
On this news, Surmodic’s price fell $10.57, or 28.31%, to close at $26.77 on January 19, 2023.
