NewsEpisurf Medical has received initial feedback from the US FDA on the IDE application for the Episealer® knee implant

Episurf Medical (NASDAQ: EPIS B) today announces that the company has received initial feedback from the US Food and Drug Administration (FDA) on the Investigational Device Exemption (IDE) application for the Episealer® knee implant that was submitted in June. The company filed the IDE application to get approval to initiate a clinical study in the US.

Episurf Medical has now received communication on the IDE application within 30 days according to FDA’s communicated timetable and now has some details to address prior to a finalised IDE study design will be set.

“We are now entering into the next phase for the IDE application. Episurf considers the FDA feedback as manageable and we are looking forward to continued work with our advisors to get the IDE study up and running according to our initial schedule” comments Pål Ryfors, CEO, Episurf Medical.

For more information, please contact:
Pål Ryfors, CEO, Episurf Medical
Tel:+46 (0) 709 62 36 69
Email: pal.ryfors@episurf.com