Episurf Medical (NASDAQ: EPIS B) today announces a status update on the previously communicated 510(k) application to the US FDA for US market clearance for the Episealer® Patellofemoral System. The present submission was filed in April this year and feedback from the substantive review has been received. The company has since been working interactively with the FDA to clarify ambiguities and provide complimentary documentation. There are planned activities to be performed during the autumn to close the remaining questions and take the review process to the final phase.

“We are on a good path with the FDA and feel we are going into a final stage where clearance should be possible in late Q4 this year or Q1 2023. We see a great need for novel alternatives in the treatment of knee osteoarthrosis and we are very excited to soon be able to offer our technology to the US healthcare system” says Pål Ryfors, CEO Episurf Medical.