Progress for Episurf Medical in initiation of Episealer® Knee IDE study
Following approval from the US Food and Drug Administration (FDA) in December 2018 for the initiation of the Episealer® Knee System IDE clinical trial, “EPIC-Knee”, Episurf Medical (NASDAQ: EPIS B) now announces further progress regarding the study initiation. The company has succeeded in recruiting a team of eminent US surgeons to serve as investigators for their trial. This past week, the company also secured Institutional Review Board (IRB) approval for the study from Western Institutional Review Board (WIRB), a central IRB that provides regulatory oversight for clinical trials across the United States. This approval allows Episurf Medical to enroll patients at all the US investigational sites.
“Preparations are underway for an Investigator Meeting to complete the pre-study surgical training, after which sites will begin recruiting patients and screening them for trial participation. The first patient is expected to be enrolled in Q2 2019”, comments Pål Ryfors, CEO, Episurf Medical.
For more information, please contact:
Pål Ryfors, CEO, Episurf Medical
Tel:+46 (0) 709 62 36 69
About Episurf Medical
Episurf Medical is endeavoring to bring people with painful joint injuries a more active, healthier life through the availability of minimally invasive and personalised treatment alternatives. Episurf Medical’s Episealer® personalised implants and Epiguide® surgical drill guides are developed for treating localized cartilage injury in joints. Episurf Medical’s μiFidelity® system enables implants to be cost-efficiently tailored to each individual’s unique injury for the optimal fit and minimal intervention. Episurf Medical’s head office is in Stockholm, Sweden. Its share (EPIS B) is listed on Nasdaq Stockholm. For more information, go to the company’s website: www.episurf.com.
This information is information that Episurf Medical AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 08.30 CET on 4 March 2019.