Episurf Medical (NASDAQ: EPIS B) today announces that the company has received initial feedback from the US Food and Drug Administration (FDA) on the Investigational Device Exemption (IDE) application for the Episealer® knee implant that was submitted in June. The company filed the IDE application to get approval to initiate a clinical study in the US.
Episurf Medical has now received communication on the IDE application within 30 days according to FDA’s communicated timetable and now has some details to address prior to a finalised IDE study design will be set.
“We are now entering into the next phase for the IDE application. Episurf considers the FDA feedback as manageable and we are looking forward to continued work with our advisors to get the IDE study up and running according to our initial schedule” 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 CEST on 30 July 2018.