Anika's Hyalofast Phase III misses co-primary endpoints; plans PMA filing by end of 2025

Anika Therapeutics, Inc.

Hyalofast missed pre-specified co-primary endpoints (percent change in KOOS Pain and IKDC function vs microfracture) on statistical significance.
Statistically significant improvements on secondary endpoints: KOOS Sports & Recreation, Quality of Life, and Total KOOS.
Safety profile comparable to microfracture; company plans to file final PMA module in H2 2025.
Over 35,000 patients treated outside U.S. since 2009; independent studies support safety and efficacy.
Study impacted by higher dropout in microfracture arm and COVID-related missed visits, reducing evaluable sample size.

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