Episurf Medical submits 510(k) application for Episealer® Patellofemoral System

Episurf Medical (NASDAQ: EPIS B) today announces that the company is now filing a 510(k) application to the US FDA for US market clearance for the Episealer® Patellofemoral System. The application is ready for filing and following certain administrative steps, it is expected that it is submitted within the next days. The application will undergo a review process. 

Episealer® Patellofemoral System is an implant system with two implants for treatment of chondral and osteochondral lesions in the knee joint. The system is based on Episurf Medical’s proprietary implant technology with individualised implants and surgical instruments, and detailed pre-surgical visualisation tools. As communicated earlier, the company is simultaneously preparing for a commercial launch in the US of the Episealer® Patellofemoral System during 2022. 

“It is gratifying to submit Episurf’s first ever 510(k) application, and I am proud of our team for the work to date on this project. We will continue to execute on this exciting initiative as we enter into the next phase, which includes the commercial preparations” says Pål Ryfors, CEO Episurf Medical.  

For more information, please contact:

Pål Ryfors, CEO, Episurf Medical
Tel:+46 (0) 709 62 36 69
Email: pal.ryfors@episurf.com

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 individualised treatment alternatives. Episurf Medical’s Episealer® individualised implants and Epiguide® surgical drill guides are developed for treating localised 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 30 December 2021.