FDAnews Device Daily Bulletin

Anika Enrolls First Patient in Hyalofast FastTRACK Trial

Jan. 4, 2016

Anika Therapeutics has enrolled the first patient in its pivotal Hyalofast FastTRACK Phase 3 clinical study.

The trial will test for the superiority of the company’s Hyalofast, a hyaluronan-based scaffold with autologous bone marrow aspirate concentrate for the treatment of articular knee cartilage defect lesions.

Roughly 200 patients will be enrolled at up to 30 sites in the U.S. and Europe.

The scaffold is CE Marked in Europe and is available commercially in 18 countries, according to Anika. — Michael Cipriano