ReconRegulatory

Episealer® Patellofemoral System – planned 510(k) submission in Q4 2021

FRI, FEB 19, 2021 08:00 CET

Episurf Medical (Nasdaq: EPIS B) today announces that the company intends to submit a 510(k) application to the US FDA regarding a two-component patellofemoral implant system, the Episealer® Patellofemoral System, during 2021. The company’s aim is to launch the product on the US market in 2022.

Patellar cartilage lesions are common and often occur in conjunction with lesions on the femoral knee joint. Episurf Medical has therefore initiated a development project to use the company’s imaging and CAD technology for a two-component system consisting of one implant for the trochlear area in the knee joint and one for patella. Both components will be individualised, cemented and have corresponding toolkits to ensure correct positioning. Whereas the trochlear component will be similar to the present Episealer® knee implant, the patellar component will be a polymer implant. 

Since an opposing patellar cartilage lesion is a contraindication for using an Episealer® knee implant in the trochlear area, we see this project as a way to expand the market to a larger group of patients. Additionally, we expect that the 510(k) regulatory pathway will enable Episurf to enter the US market significantly earlier than with the ongoing IDE study”, says Pål Ryfors, CEO, Episurf Medical.

The FDA submission is expected to take place in Q4 2021 and feedback from the FDA is expected in Q1 2022.

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, 08.00 CET on February 19, 2021.

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Chris J. Stewart

Chris currently serves as President and CEO of Surgio Health. Chris has close to 20 years of healthcare management experience, with an infinity to improve healthcare delivery through the development and implementation of innovative solutions that result in improved efficiencies, reduction of unnecessary financial & clinical variation, and help achieve better patient outcomes. Previously, Chris was assistant vice president and business unit leader for HPG/HCA. He has presented at numerous healthcare forums on topics that include disruptive innovation, physician engagement, shifting reimbursement models, cost per clinical episode and the future of supply chain delivery.

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