Anika reports filing of final PMA module for Hylofast cartilage repair

Anika Therapeutics (ANIK) announced that it filed the third and final module of its Premarket Approval application, PMA, for Hyalofast-its resorbable, hyaluronic acid-based scaffold used with autologous bone marrow aspirate concentrate, BMAC, for treating articular cartilage defects in the knee. The Company also reported results from its U.S. pivotal Phase III FastTRACK clinical trial evaluating Hyalofast. On October 31, 2025, Anika submitted the third and final module of its Hyalofast PMA to the U.S. Food and Drug Administration. The PMA includes FastTRACK 24-month data and incorporates additional post-hoc analyses and real-world data.