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Anika Therapeutics Topline Results From Its US Pivotal Trial Of Hyalofast For Articular Knee Cartilage Defect Lesions Demonstrated Improvements Over Microfracture, But Missed On Statistical Significance Of The Pre-specified Co-primary Endpoints

Author: Benzinga Newsdesk | July 30, 2025 06:10am

Hyalofast consistently demonstrated improvements over microfracture, but missed on statistical significance of the pre-specified co-primary endpoints of percent change in KOOS Pain and IKDC function
Hyalofast showed statistically significant improvements over microfracture in pre-defined secondary endpoints and other measures that align with prior FDA approvals for cartilage repair products
Hyalofast has been used to treat over 35,000 patients in more than 35 countries outside the U.S. since 2009; data from independent studies performed outside the U.S. will be filed with FDA submission
Based on the totality of the data, Anika plans to file the final PMA module in H2 2025

Posted In: ANIK