Episurf Medical provides update on 510(k) application
Episurf Medical (NASDAQ: EPIS B) today announces a status update on the previously communicated 510(k) application to the US FDA for US market clearance for the Episealer® Patellofemoral System. The present submission was filed in April this year and feedback from the substantive review has been received. The company has since been working interactively with the FDA to clarify ambiguities and provide complimentary documentation. There are planned activities to be performed during the autumn to close the remaining questions and take the review process to the final phase.
“We are on a good path with the FDA and feel we are going into a final stage where clearance should be possible in late Q4 this year or Q1 2023. We see a great need for novel alternatives in the treatment of knee osteoarthrosis and we are very excited to soon be able to offer our technology to the US healthcare system” 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 CEST on 21 September 2022.