Anika Reports Topline Results from U.S. Pivotal FastTRACK Phase III Study for Hyalofast® Cartilage Repair Scaffold and Provides Program Update

Core Insights - Anika Therapeutics announced topline results from its pivotal clinical trial of Hyalofast, a hyaluronic acid scaffold for cartilage repair, which showed improvements over microfracture but did not meet the pre-specified co-primary endpoints [2][4][6] - The company plans to file the final PMA module for Hyalofast in the second half of 2025, including additional analyses and data from independent studies conducted outside the U.S. [5][7] Clinical Trial Results - The FastTRACK study aimed to establish the superiority of Hyalofast with autologous BMAC over microfracture, with co-primary endpoints focused on KOOS pain and IKDC function scores [3] - Although Hyalofast showed consistent improvements in pain and function measures, it did not achieve statistical significance for the co-primary endpoints due to higher dropout rates and missed visits during COVID [4][6] Safety and Effectiveness - Hyalofast demonstrated statistically significant improvements in secondary endpoints, including KOOS Sports and Recreation Function and Quality of Life, supporting its safety and effectiveness profile [5][6] - The product has been used to treat over 35,000 patients in more than 35 countries since its launch in 2009, with positive long-term outcomes reported [5][8] Regulatory Plans - Anika plans to submit the third and final PMA module in H2 2025, which will include ongoing post-hoc analyses and additional endpoints previously accepted by the FDA [7] - The FDA has designated Hyalofast as a breakthrough device, allowing for prioritized review and interaction [8]