Surmodics Stock Slides Following Regulatory Setback For Its SurVeil Drug-Coated Balloon

  • Surmodics Inc SRDX has received a letter from the FDA 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 on 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.
  • After the above setback, the company plans to evaluate options to reduce the use of cash.
  • The SurVeil DCB, a next-generation device for peripheral artery disease (PAD), includes a proprietary drug-excipient formulation using an innovative process to improve coating uniformity. 
  • Price Action: SRDX shares are down 20.19% at $29.80 on the last check Thursday.
  • Photo Via Company
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