Episurf Medical announced that a 510(k) filing to the US FDA for market clearance of the company's toe implant for the 1st MTP joint is being submitted. The submission will now undergo a review process and 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, a disease affecting several million Americans each year. It is based on Episurf Medical's proprietary technology for patient-specific design of implants and surgical instruments. The product is estimated to expand the company's total addressable market by approximately $400 million while adding over 10,000 surgeons to the company's target customer list.