By Colin Kellaher


Surmodics Inc. on Thursday said the U.S. Food and Drug Administration has turned away its application seeking approval of its SurVeil drug-coated balloon for the treatment of peripheral artery disease.

The Eden Prairie, Minn., company said that while the FDA indicated that the application isn't currently approvable, the agency provided specific guidance on a path forward, including the addition of biocompatibility and labeling information in an amendment to the application.

Surmodics said the information sought by the FDA will require additional testing and analysis, but the company also noted that the agency didn't request any further human clinical data.

Surmodics said it plans to meet with the FDA to discuss the issues raised by the agency, and that it will determine the appropriate path forward based on those talks. In the meantime, the company said it is looking at options to reduce its cash burn.

Shares of Surmodics, which closed Wednesday at $37.34, were recently down 8.9% at $34 in light premarket trading.


Write to Colin Kellaher at colin.kellaher@wsj.com


(END) Dow Jones Newswires

01-19-23 0742ET