Anika Therapeutics, Inc. announced that it has completed enrollment of the pivotal Phase III clinical study for Hyalofast (Hyalofast 15-01) on its path to achieving FDA approval in the United States. Hyalofast is a highly differentiated, single-stage, bone preserving, hyaluronic acid (HA) matrix and its approval would immediately position Anika as a leader in the regenerative knee cartilage repair market, which is growing at a 5-year CAGR of 11% and is expected to reach in excess of $350 million by 2025. Unlike the current standard of care which requires two surgeries, removal of autologous cartilage, cell expansion, and subsequent cell reimplantation at the diseased site, or an alternative product that requires removing healthy bone to accommodate an implant, Hyalofast is implanted in just a single surgery following debridement of only the diseased tissue.

In addition to reducing the burden on patients and the healthcare system, Hyalofast is stocked at the surgical facility and can simply be pulled off the shelf during surgery when a cartilage lesion is identified. Hyalofast is already marketed in more than 35 countries outside the U.S. and is truly a game changing treatment for patients with pain and decreased function caused by cartilage lesions. The U.S. cartilage repair market has been constrained by the need for surgeons to perform, and patients to endure, a second surgical procedure in order to use the product on the market today.

The off-the-shelf, bone-preserving design of Hyalofast allows surgeons to quickly repair lesions intraoperatively, without the need for a second costly, invasive surgery. FDA has granted Anika Breakthrough Device Designation for the Hyalofast plus autologous bone marrow aspirate concentrate (BMAC) combination product. The Breakthrough Device Program is a voluntary program for certain medical devices that are aimed at providing more effective treatment of life-threatening or irreversibly debilitating diseases or conditions.

It offers Anika the opportunity to engage with FDA on a prioritized basis to efficiently address topics as they arise during the premarket review phase, ultimately enabling patients' faster access to new therapies. The Company has also obtained agreement from FDA to file a modular PMA submission and expects to file the first module of the application in 2024. This allows Anika to file product and manufacturing information while continuing to collect and analyze clinical data, making the regulatory review process more efficient.

The final module with clinical data is expected to be filed in 2025. In the U.S., Hyalofast would join Tactoset® Injectable Bone Substitute in Anika's regenerative portfolio, as well as other products in the regenerative pipeline including the HA-based, arthroscopic patch system. Tactoset is an HA and calcium phosphate based, biocompatible bone graft substitute that is highly flowable, easily injectable, settable, and interdigitates into the trabecular bone architecture with improved handling characteristics compared to other competitive products.

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