Episurf Medical: Approaching 510(k) submission for big toe implant
Episurf Medical (NASDAQ: EPIS B) today provides an update on the planned 510(k) filing to the US FDA for the company’s implant for the 1[st] MTP joint of the big toe. The company plans to file the 510(k) submission for US market clearance during the coming weeks. The company aims to receive clearance to be able to launch the product on the US market during 2024. The company is currently assessing various options for commercialization strategy, including independent distributors and technology licensing. The implant is intended to treat osteoarthritis (hallux rigidus) in the big toe. It