The implant is intended to treat osteoarthritis (hallux rigidus) in the big toe, and more specifically of the so-called 1st MTP joint. It is based on Episurf Medical's proprietary technology for patient-specific design of implants and surgical instruments.  

"I am pleased with having our plans finally confirmed, and I look forward to working with the FDA on this very interesting product. The market for osteoarthritis in the big toe is large, expanding our total addressable market in the US by about USD 400 million. Although the US market is our initial target market for this product, we aim at also launching it in non-US countries in the years to come. About 2.5% of the US population over the age of 50 suffers from OA in the big toe, and the market remains highly fragmented with no clear winner. Surgeons repeatedly mention patients' desire to retain motion by avoiding fusion, and the orthopaedic industry's lack of ability to meet this demand effectively. This is where we believe our fully individualized technology will play a meaningful role, and yet again, we are capitalising on our platform for individualized joint reconstruction products", says Pål Ryfors, CEO Episurf Medical.