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Anika Therapeutics completed enrollment of the pivotal Phase III clinical study for Hyalofast in the United States.
Hyalofast is a single-stage bone-preserving hyaluronic acid (HA) matrix. It offers an alternative to the current standard of care, which requires two surgeries, removal of autologous cartilage, cell expansion and subsequent cell reimplantation at the diseased site, or a product that requires removing healthy bone to accommodate an implant. Hyalofast is implanted in a single surgery following debridement of only the diseased tissue. 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. FDA has granted Anika Breakthrough Device Designation for the Hyalofast plus autologous bone marrow aspirate concentrate (BMAC) combination product. 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. The final module with clinical data is expected to be filed in 2025.
“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.”
Source: Anika
Anika Therapeutics completed enrollment of the pivotal Phase III clinical study for Hyalofast in the United States.
Hyalofast is a single-stage bone-preserving hyaluronic acid (HA) matrix. It offers an alternative to the current standard of care, which requires two surgeries, removal of autologous cartilage, cell expansion and subsequent cell...
Anika Therapeutics completed enrollment of the pivotal Phase III clinical study for Hyalofast in the United States.
Hyalofast is a single-stage bone-preserving hyaluronic acid (HA) matrix. It offers an alternative to the current standard of care, which requires two surgeries, removal of autologous cartilage, cell expansion and subsequent cell reimplantation at the diseased site, or a product that requires removing healthy bone to accommodate an implant. Hyalofast is implanted in a single surgery following debridement of only the diseased tissue. 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. FDA has granted Anika Breakthrough Device Designation for the Hyalofast plus autologous bone marrow aspirate concentrate (BMAC) combination product. 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. The final module with clinical data is expected to be filed in 2025.
“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.”
Source: Anika
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Julie Vetalice is ORTHOWORLD's Editorial Assistant. She has covered the orthopedic industry for over 20 years, having joined the company in 1999.
