Episurf Medical submits follow-up 510(k) application for Episealer® Patellofemoral System
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 company has during Q1 had a dialogue with the FDA and has concluded that the necessary amendments are best addressed by a follow-up 510(k) application, addressing feedback from the FDA. The application will be filed within a few days and will undergo a review process with 90 days review time.
Episealer® Patellofemoral System is an implant system with two opposing implants, intended for patients with osteoarthritis limited to the patellofemoral joint of the knee.
“We are looking forward to continued work to get the product ready for the US market. We have addressed the feedback obtained and feel that we are with this a step closer to clearance. This device can really make a difference for patients with patellofemoral joint pain, and we don’t see that this additional filing will have any significant impact on the timeline for a coming launch on the US market” 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 13.45 CEST on 7 April 2022.
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