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Hyalofast is a resorbable, off-the-shelf, hyaluronic acid-based scaffold designed for the repair of articular cartilage defects, particularly in the knee. Developed by Anika Therapeutics, it is typically used in a single-stage surgical procedure in conjunction with autologous bone marrow aspirate concentrate (BMAC). The scaffold is composed of HYAFF-11, a benzyl ester of hyaluronic acid, which provides a three-dimensional microenvironment that supports the attachment, proliferation, and differentiation of mesenchymal stem cells, facilitating the regeneration of hyaline-like cartilage. While it has been marketed internationally in over 35 countries since 2009, it is currently under regulatory review in the U.S. via the Pre-Market Approval (PMA) pathway, supported by the FastTRACK pivotal study and Breakthrough Device Designation.
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