Surmodics had anticipated winning FDA approval for its highly-anticipated SurVeil Drug-Coated Balloon by the end of last year, however the process has taken longer than expected due to additional data requests from the agency.

During the company's most recent earnings call, Surmodics' executives noted that FDA approval is now likely to come by the end of its first quarter in fiscal year 2023, which would still be in calendar year 2022.

Once approved, the company is due to collect a milestone payment from Abbott, its commercial partner, of about $25 million.