Core Insights - Anika Therapeutics has filed the third and final module of its Premarket Approval application for Hyalofast, a hyaluronic acid-based scaffold for treating knee cartilage defects [1][2] - The company reported results from the U.S. pivotal Phase III FastTRACK clinical trial, which evaluated the efficacy of Hyalofast [3] Clinical Trial Overview - The FastTRACK study, initiated in 2015, was a randomized, active treatment-controlled trial designed to establish the superiority of Hyalofast combined with BMAC over microfracture, the standard of care at the time [4] - The study enrolled patients with symptomatic cartilage lesions and monitored outcomes for two years [4] Primary Endpoints Results - The study did not meet its pre-specified co-primary endpoints; KOOS Pain scores showed an 8.11% difference favoring microfracture (p=0.81), while IKDC Function scores showed a 4.84% difference favoring Hyalofast (p=0.34) [5] - High variability in baseline scores, particularly in the microfracture arm, influenced these results [5] Post-Hoc Analysis - A post-hoc analysis without imputation showed Hyalofast demonstrated a 23.37% improvement over microfracture in KOOS Pain score (p=0.02) and an absolute difference of 4.54 points (p=0.02) [6] Secondary Endpoints Results - Hyalofast showed statistically significant improvements in key secondary endpoints, including a 12.19-point gain in KOOS Sports and Recreation scores (p=0.01) and a 9.52-point improvement in KOOS Quality of Life scores (p=0.03) [7] - Total KOOS, a composite measure of pain and function, improved by 6.57 points (p=0.02) compared to microfracture [7] Responder Analysis - A responder analysis indicated that 87.4% of Hyalofast patients achieved at least a 10-point improvement in KOOS Pain compared to 75.3% of microfracture patients (p=0.050) [9] - At higher thresholds, Hyalofast patients showed even greater advantages, with 72.8% achieving a 20-point improvement compared to 52.6% in the microfracture group (p=0.029) [9] Clinical and Regulatory Implications - Despite not meeting pre-specified co-primary endpoints, the company remains confident in Hyalofast's clinical value, citing significant improvements in secondary endpoints [10] - Anika has treated over 35,000 patients globally with Hyalofast since 2009, reporting positive long-term outcomes [10] Product Information - Hyalofast is an off-the-shelf, single-stage scaffold designed to support the regeneration of hyaline-like cartilage and is marketed in over 35 countries [11]

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]