Surmodics returns to the drawing board as FDA declares drug-coated balloon 'not currently approvable'

Surmodics looks to pave a new path forward after the FDA sent a device submission back for revision yet again.

The device in question is its SurVeil drug-coated balloon, which is threaded into a blood vessel and inflated to open blocked or narrowed areas to help treat peripheral artery disease. The SurVeil system—which uses materials the company claims allow for a more uniform coating of the balloons—received CE mark clearance in Europe in 2020.

It’s been a different story on the U.S. side of the pond. Though Surmodics first submitted the balloon to the FDA for premarket approval in mid-2021, after wrapping up a clinical trial of the device, the agency soon issued a request for even more clinical data. Now, despite providing that additional information toward the end of last year, Surmodics’ application has once again been deferred.

The Minnesota-based company announced Thursday it received another letter from the FDA indicating that SurVeil is “not currently approvable.”

Fortunately for Surmodics, the agency didn’t ask for any additional clinical data, nor did it question the trial results already submitted. Instead, the company said, the FDA is looking for additional information about SurVeil’s biocompatibility and labeling that can be submitted as an amendment to the existing premarket approval application.

Gary Maharaj, Surmodics’ CEO, said the company is in the process of “evaluating the issues raised in the FDA’s letter” and is planning to meet with members of the agency to discuss the letter. The update has also seemingly thrown off Surmodics’ financial outlook for the year, with Maharaj adding that “we will be evaluating options to reduce our use of cash given this development,” with further updates to come in its next earnings call.

“We are disappointed by the FDA’s response to our PMA application and continue to have confidence in our SurVeil DCB including its compelling performance in the Transcend clinical study,” Maharaj said.

Maharaj gave a full recap of the premarket submission in Surmodics’ most recent call with investors, which took place in early November. After sending in the initial application toward the end of June 2021, Surmodics “received a request from the agency for additional data to support their review,” he said, according to a transcript of the call.

The company then had to spend most of the next fiscal year working with the FDA to meet the criteria and dispatching its clinical team to collect the needed data and test results through work with independent testing labs. Surmodics wrapped up that work and sent in the final addenda on Oct. 13, and Maharaj said in the call that the company was hoping to finally receive the FDA’s blessing by the end of its second fiscal quarter of 2023, which ends March 31.

The company has a lot riding on the regulatory approval: Under the terms of a 2018 deal that gave Abbott exclusive commercialization rights to the SurVeil device, Surmodics stands to collect a multi-million-dollar milestone payment once it secures premarket approval, though the dollar amount drops as time goes on. As Maharaj detailed in the November call, Surmodics could’ve earned $30 million if the approval came before Dec. 31, 2022; now, Abbott will pay out either $27 million or, if the approval doesn’t arrive by June 30 of this year, $24 million as a reward for the milestone.