Episurf Medical: Update on 510(k) application for big toe implant

Episurf Medical (Nasdaq: EPIS B) today provides an update on the company's 510(k) application to the US FDA, for market clearance of the company's implant for treatment of osteoarthritis in the so-called 1st MTP joint in the big toe. During this process, the company has exchanged information with the FDA, and this process will continue shortly.

"We are pleased to have come this far in the process. We have in-depth experience of interacting with the FDA, and we know that it is difficult to forecast these processes accurately, but we certainly feel that we are moving forward. We will not reach our goal of FDA clearance in 2024, but we aim for the first six months of 2025, hoping to achieve our goal as early as possible in 2025. While the timeline has shifted slightly, our confidence in obtaining approval has recently strengthened.

We see a completely different type of commercial opportunity ahead of us in the US than before, which is why we look forward to positively completing this project," says Pål Ryfors, CEO of Episurf Medical.