Anika Completes Enrollment in Hyalofast U.S. Pivotal Phase III Study Achieving Key Milestone

Hyalofast – a single-stage, off-the-shelf, resorbable, hyaluronic acid scaffold for cartilage repair – is marketed in over 35 countries outside the U.S. where it has been clinically demonstrated to be safe and effective

Hyalofast has been designated as a breakthrough device by FDA, allowing prioritized interaction and review; Anika to begin filing modular PMA in 2024 with final module filing expected in 2025

Hyalofast positions Anika to lead and expand the over $350 million¹ U.S. knee cartilage repair market with significant benefits for all stakeholders in the healthcare system

BEDFORD, Mass., May 30, 2023 (GLOBE NEWSWIRE) -- Anika Therapeutics, Inc. (NASDAQ: ANIK), a global joint preservation company focused on early intervention orthopedics, today 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 2025¹. 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.

“This is an important milestone for Anika, bringing us one step closer to making Hyalofast available for patients in the United States,” said Anika’s President and CEO, Cheryl R. Blanchard, Ph.D. “The knee cartilage repair market in the U.S. is large and growing and is perfectly aligned with our strategic focus as we continue to introduce groundbreaking regenerative solutions that expand our Joint Preservation and Restoration portfolio. We believe that Hyalofast will drive significant market expansion and further accelerate our company’s growth in the coming years. We are pleased that FDA has granted Hyalofast Breakthrough Device Designation and has agreed to a modular PMA filing, both of which will facilitate an efficient review process.”