Episurf Medical received FDA approval for its Investigational Device Exemption (IDE) application to initiate a clinical trial of the Episealer® knee implant. The two-year prospective, randomized, controlled, multi-center study will evaluate the device vs. microfracture in the treatment of focal femoral knee chondral or osteochondral lesions in 180 patients in the U.S. and Europe.
Patient enrollment may start once Institutional Review Board approval is obtained. Additional conditions must be met to address minor outstanding issues, but these have not raised concerns that preclude FDA from granting approval.
Episurf first announced its U.S. regulatory path intentions in 2Q17, and subsequently filed its IDE in 2Q18.
The company has developed Episealer personalized implants and Epiguide® drill guides to treat localized joint cartilage injury. Since 2013, Episurf has gained approval under the CE Mark for numerous technologies and marketing approval in Hong Kong, Israel, Poland and Spain, and has received patent allowances around the globe.
Sources: Episurf Medical AB; ORTHOWORLD Inc.