Episurf Medical gained approval from Agencia Española de Medicamentos y Productos Sanitarios, the regulatory office in Spain, to market the Episealer® knee implant.
The company has developed Episealer® personalized implants and Epiguide® surgical 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 Israel for Episealer products, and has received patent allowances around the globe.
Per the company's 2017 Annual Report, Episurf plans to launch a large multicenter Investigational Device Exemption clinical trial in the U.S. and Europe. The study will support an eventual premarket approval application to FDA.
Source: Episurf Medical