FDA Clears Episealer Patellofemoral System

Episurf Medical has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the Episealer Patellofemoral System.

“To date, this likely represents the single most significant milestone in the company’s history. The company now has access to the largest and most dynamic orthopedic market in the world and we have come a very long way, indeed, since our first animal investigations nearly 15 years ago,” Episurf Founder and Senior Medical Advisor Prof. Leif Ryd said. “The patellofemoral implant system replaces both sides of the patellofemoral joint of the knee. This means that our technology can now treat not only focal lesions in the cartilage but also overt osteoarthritis. Hence, we can now serve a broader span of indications.” 
 
The Episealer Patellofemoral System is an implant system with two opposing implants, intended for patients with osteoarthritis limited to the distal patellofemoral knee joint. It is based on Episurf Medical’s proprietary individualised implant technology.
 
Episurf Medical will now prepare for the market launch of the company’s first product on the U.S. market. 
 
“Gaining access to the U.S. market symbolises a significant step for any orthopedic implant manufacturer. For Episurf, this clearance represents somewhat of a double milestone. Firstly, there is the obvious access to the U.S. orthopaedic market, which is of significant size and by far the largest orthopedic market in the world. However, this clearance represents not only an additional country we are able to sell into, but a new product for the company as well—and our initial entry into treating osteoarthritis as a clinical indication,” CEO Pål Ryfors said. “The patellofemoral joint is one of the higher variance anatomic locations in the musculoskeletal system, and we’re confident our individualised technology will be able to play a meaningful role towards advancing care in this area.” 
 
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.