Episurf Medical receives FDA approval to initiate IDE clinical study
Episurf Medical (NASDAQ: EPIS B) announces today that the company has received approval from the US Food and Drug Administration (FDA) for its Investigational Device Exemption (IDE) application to initiate a clinical study on the Episealer® knee implant. The study will be a prospective, randomized, controlled, multi-centre study to evaluate the safety and effectiveness of the Episealer® knee system compared to microfracture for the treatment of focal femoral knee chondral or osteochondral lesions. The study will be performed both in the US and in Europe. The patients will be followed-up for