Maxx Orthopedics, Inc.

FDA Approves Clinical Trial for PEEK-OPTIMA Knee Implant

- The FDA has granted Investigational Device Exemption (IDE) approval for the Freedom® Total Knee System with Invibio PEEK-OPTIMA™ Femoral Component. - A study involving 120 patients across US clinical sites will compare the PEEK-OPTIMA™ component against traditional metal components in total knee arthroplasty. - This US study builds upon ongoing clinical trials in Belgium, India, and Italy, which have shown promising results since the first implant in 2021. - Regulatory submission in India is expected imminently, potentially leading to commercial availability of the PEEK Knee in 2025.