Episurf Medical entered into a distribution agreement with Pacific Medical Systems in Hong Kong, its first market in China, and established a U.S. subsidiary to conduct clinical studies in support of its regulatory path.
Previously, the company had announced that a pre-submission meeting with FDA had occurred in 3Q16, with submission of a 513(g) request regarding classification and regulatory requirements that may apply to the Episealer® device.
Per the company's 2017 year-end report, an Investigational Device Exemption clinical trial is planned in U.S. and European centers for Episealer knee implants and will be part of a premarket approval application to FDA.
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.