Anika Therapeutics, Inc. (NASDAQ:ANIK), a $160 million market cap healthcare company trading near its 52-week low of $10.47, announced Wednesday that its Hyalofast cartilage repair treatment did not meet the pre-specified co-primary endpoints in its U.S. pivotal clinical trial, despite showing consistent improvements over microfracture treatment. According to InvestingPro data, the company maintains a healthy gross profit margin of 61.78% despite recent challenges.
The FastTRACK study evaluated Hyalofast, a resorbable hyaluronic acid scaffold used with autologous bone marrow aspirate concentrate, against microfracture for knee cartilage defect repair. While Hyalofast demonstrated improvements in pain and function measures, it failed to achieve statistical significance in the two co-primary endpoints: percent change in KOOS Pain and IKDC function scores.
The company attributed the statistical shortfall partly to higher dropout rates in the microfracture control group and missed visits during COVID, which reduced the evaluable sample size.
Despite missing primary endpoints, Hyalofast showed statistically significant improvements in pre-defined secondary endpoints, including KOOS Sports and Recreation Function, Quality of Life, and Total KOOS composite score. The company noted these measures have supported prior FDA approvals for cartilage repair products.
"While we are disappointed that the co-primary endpoints were not achieved under the original statistical framework, we are encouraged by the consistency and robustness of our results," said Cheryl Blanchard, President and CEO of Anika Therapeutics, in the press release.
Hyalofast has been used to treat over 35,000 patients in more than 35 countries outside the U.S. since 2009. Anika plans to file the final PMA module with the FDA in the second half of 2025, including additional post-hoc analyses and data from independent studies performed outside the U.S.
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