Episurf Submits IDE Application for Episealer Knee

By Julie A. Vetalice

By the end of 2Q18, Episurf Medical will file its Investigational Device Exemption with FDA to initiate a U.S. study of the Episealer® knee implant.

In early 2Q, the company affirmed the establishment of its U.S. subsidiary to conduct clinical studies in support of its regulatory path.

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; ORTHOWORLD Inc.

Product Labels: Knee Replacement

Tags: Regulatory