FDA demands additional data on Abbott rival to Medtronic balloon, setting back approval timeline

Dive Brief:

The Food and Drug Administration has demanded additional data on Abbott and Surmodics’ drug-coated balloon, setting back the companies’ plans to bring the device to market.
Responding to a premarket approval (PMA) filing, the FDA said it cannot authorize the peripheral artery disease device on the available information. Surmodics will need to complete “additional testing and analysis” to address the FDA’s concerns.
Surmodics has yet to decide on the next steps and is “evaluating options” to reduce its spending in light of the setback. The device coating company had $19 million in cash and investments at the end of September.

Dive Insight:

Abbott paid $25 million upfront for the global rights for the device, SurVeil drug-coated balloon, in 2018 to add a rival to Medtronic’s IN.PACT Admiral drug-coated balloon to its pipeline. Fears about the safety of medical devices coated with paclitaxel, the drug used in SurVeil, led to a brief pause in clinical trial enrollment the following year, but the partners pushed on thereafter and showed SurVeil matched the performance of IN.PACT Admiral.

Surmodics said it had expected the dataset to support approval. While the FDA “did not question the human clinical data submitted nor request any further human clinical data,” it indicated “the application is not currently approvable,” requesting certain biocompatibility and labeling information, Surmodics wrote in a summary of the letter.

Additional testing and analysis will be needed to generate the information requested by the FDA. Surmodics is still evaluating how to proceed, CEO Gary Maharaj said in a statement.

“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,” Maharaj said.

The delay could affect how much money Surmodics receives from Abbott. Had the FDA approved the device last year, Abbott would have made a $30 million milestone payment to Surmodics. The milestone for an approval in the first half of 2023 is $27 million, and will fall again to $24 million if Surmodics has to wait until June 30 for a positive decision from the regulator.

Shares in Surmodics fell 29% to $26.38 in trading on Nasdaq on Thursday.