Episurf Medical

Episurf Medical (NASDAQ: EPIS B) today announces that the first surgery in Canada within the company's IDE Clinical Trial, EPIC-Knee: Episealer® Knee System IDE Clinical Study, is scheduled. The randomised controlled IDE study is currently ongoing in the USA/Canada and Europe, and surgeries have this far been performed in Tennessee and California in the US, as well as in Germany. The end goal with the study is an FDA PMA application for US market approval the Episealer® Knee implant.

"This is a milestone in this important study. We have had challenges with the speed of recruitment for the study, but lately we have seen increased activity, which pleases us. For example, we also have the first operation in Texas scheduled, and we have new investigators being added in Europe", says Pål Ryfors, CEO Episurf Medical.

Since previously, the Episealer® Patellofemoral System is cleared for sale in the US, and the company is intending to submit an FDA 510(k)-application for its implant for the 1st MTP joint (big toe) in the near future.