Episurf Medical is entering its next phase for Investigational Device Exemption (IDE) to initiate a U.S. clinical study of the Episealer® knee implant, having submitted its application in mid-2Q18 as planned and now received FDA feedback.
The company has additional details to address prior to setting a finalized IDE study design. “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,” said Pål Ryfors, Chief Executive Officer.
Episurf has developed Episealer personalized implants and Epiguide® drill guides to treat localized joint cartilage injury. Since 2013, the company has gained approval under the CE Mark for numerous technologies and marketing approval in Israel and Spain, and has received patent allowances around the globe.
Sources: Episurf Medical AB; ORTHOWORLD Inc.