Michael Barbella, Managing Editor05.31.23
Anika Therapeutics Inc. has completed enrollment of the pivotal Phase III clinical study for Hyalofast (Hyalofast 15-01) on its path to achieving U.S. Food and Drug Administration (FDA) approval.
Hyalofast is a highly differentiated, single-stage, bone preserving, hyaluronic acid (HA) matrix and its approval would position Anika as a leader in the regenerative knee cartilage repair market, which is growing 11% annually and is expected to top $350 million by 2025.1 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 a single surgery after diseased tissue is debrided. In addition to reducing the burden on patients and the healthcare system, Hyalofast is stocked at the surgical facility and can 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,” Anika President/CEO Cheryl R. Blanchard, Ph.D., said. “The knee cartilage repair market in the U.S. is large and growing and is aligned with our strategic focus as we continue to introduce regenerative solutions that expand our Joint Preservation and Restoration portfolio. We believe Hyalofast will drive significant market expansion and further accelerate our company’s growth in the coming years. We are pleased the FDA has granted Hyalofast Breakthrough Device Designation and has agreed to a modular PMA filing, both of which will facilitate an efficient review process.”
Hyalofast is already marketed in more than 35 countries outside the United States and is a 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 current products on the market. 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 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 United States, 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. While widely used to treat insufficiency fractures, it is also indicated for use with the augmentation of hardware, such as suture anchors.
Hyalofast is a biodegradable, resorbable, non-woven scaffold composed of HYAFF fibers. HYAFF is Anika’s proprietary solid form of HA, composed of a benzyl ester of hyaluronic acid. It is intended as support for the entrapment of mesenchymal stem cells obtained from autologous bone marrow aspirate concentrate (BMAC) for the repair of chondral and osteochondral lesions. Hyalofast is implanted into a cartilage lesion with BMAC and fills the defect until it is eventually resorbed and replaced by new, hyaline like cartilage that integrates with the surrounding tissues. Hyalofast allows for the repair of both chondral and osteochondral lesions without removing healthy subchondral bone.
Outside the United States, Hyalofast has been clinically demonstrated to be safe and effective in medium to long-term follow up in the repair of ankle and knee chondral and osteochondral lesions. More than 40 Hyalofast clinical publications representing more than 10 years of clinical data show that patients consistently report reduced pain and improved joint function, enabling them to return to their active lifestyle with substantial pain relief and high satisfaction.2 Hyalofast has also demonstrated a strong safety profile since being placed on the market outside the United States in 2009.
The Hyalofast 15-01 study is a prospective, randomized, active treatment-controlled, evaluator-blinded multicenter study to establish the superiority of Hyalofast with autologous BMAC in treating articular knee cartilage defect lesions in comparison to microfracture as a control. The current enrolled study involves 200 subjects randomized one to one versus microfracture with co-primary endpoints being the percentage change in KOOS Pain Score from baseline to two years and percentage change in IKDC Subjective from baseline to two years. The study, which began in 2015, was significantly delayed due to COVID-19's impact on new site initiation and elective surgical procedures. Hyalofast plus BMAC is a device-biologic combination product that will be subject to a premarket approval application (PMA) under the jurisdiction of FDA’s Center for Biologics Evaluation and Research.
Anika Therapeutics is a global joint preservation company that creates and delivers advancements in early intervention orthopedic care. Leveraging its core expertise in hyaluronic acid and implant solutions, the firm partners with clinicians to provide minimally invasive products that restore active living for people. Its focus is on high opportunity spaces within orthopedics, including osteoarthritis pain management, regenerative solutions, sports medicine, and arthrosurface joint solutions, and its products are delivered in key care sites, including ambulatory surgery centers. Anika’s global operations are headquartered outside of Boston.
References
1 SmartTRAK and Anika estimates
2 Gobbi A et al. Long-term Clinical Outcomes of One-Stage Cartilage Repair in the Knee with Hyaluronic Acid-Based Scaffold Embedded with Mesenchymal Stem Cells Sourced From Bone Marrow Aspirate Concentrate. Am J Sports Med. 2019 May 16; Additional data on file.
Hyalofast is a highly differentiated, single-stage, bone preserving, hyaluronic acid (HA) matrix and its approval would position Anika as a leader in the regenerative knee cartilage repair market, which is growing 11% annually and is expected to top $350 million by 2025.1 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 a single surgery after diseased tissue is debrided. In addition to reducing the burden on patients and the healthcare system, Hyalofast is stocked at the surgical facility and can 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,” Anika President/CEO Cheryl R. Blanchard, Ph.D., said. “The knee cartilage repair market in the U.S. is large and growing and is aligned with our strategic focus as we continue to introduce regenerative solutions that expand our Joint Preservation and Restoration portfolio. We believe Hyalofast will drive significant market expansion and further accelerate our company’s growth in the coming years. We are pleased the FDA has granted Hyalofast Breakthrough Device Designation and has agreed to a modular PMA filing, both of which will facilitate an efficient review process.”
Hyalofast is already marketed in more than 35 countries outside the United States and is a 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 current products on the market. 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 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 United States, 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. While widely used to treat insufficiency fractures, it is also indicated for use with the augmentation of hardware, such as suture anchors.
Hyalofast is a biodegradable, resorbable, non-woven scaffold composed of HYAFF fibers. HYAFF is Anika’s proprietary solid form of HA, composed of a benzyl ester of hyaluronic acid. It is intended as support for the entrapment of mesenchymal stem cells obtained from autologous bone marrow aspirate concentrate (BMAC) for the repair of chondral and osteochondral lesions. Hyalofast is implanted into a cartilage lesion with BMAC and fills the defect until it is eventually resorbed and replaced by new, hyaline like cartilage that integrates with the surrounding tissues. Hyalofast allows for the repair of both chondral and osteochondral lesions without removing healthy subchondral bone.
Outside the United States, Hyalofast has been clinically demonstrated to be safe and effective in medium to long-term follow up in the repair of ankle and knee chondral and osteochondral lesions. More than 40 Hyalofast clinical publications representing more than 10 years of clinical data show that patients consistently report reduced pain and improved joint function, enabling them to return to their active lifestyle with substantial pain relief and high satisfaction.2 Hyalofast has also demonstrated a strong safety profile since being placed on the market outside the United States in 2009.
The Hyalofast 15-01 study is a prospective, randomized, active treatment-controlled, evaluator-blinded multicenter study to establish the superiority of Hyalofast with autologous BMAC in treating articular knee cartilage defect lesions in comparison to microfracture as a control. The current enrolled study involves 200 subjects randomized one to one versus microfracture with co-primary endpoints being the percentage change in KOOS Pain Score from baseline to two years and percentage change in IKDC Subjective from baseline to two years. The study, which began in 2015, was significantly delayed due to COVID-19's impact on new site initiation and elective surgical procedures. Hyalofast plus BMAC is a device-biologic combination product that will be subject to a premarket approval application (PMA) under the jurisdiction of FDA’s Center for Biologics Evaluation and Research.
Anika Therapeutics is a global joint preservation company that creates and delivers advancements in early intervention orthopedic care. Leveraging its core expertise in hyaluronic acid and implant solutions, the firm partners with clinicians to provide minimally invasive products that restore active living for people. Its focus is on high opportunity spaces within orthopedics, including osteoarthritis pain management, regenerative solutions, sports medicine, and arthrosurface joint solutions, and its products are delivered in key care sites, including ambulatory surgery centers. Anika’s global operations are headquartered outside of Boston.
References
1 SmartTRAK and Anika estimates
2 Gobbi A et al. Long-term Clinical Outcomes of One-Stage Cartilage Repair in the Knee with Hyaluronic Acid-Based Scaffold Embedded with Mesenchymal Stem Cells Sourced From Bone Marrow Aspirate Concentrate. Am J Sports Med. 2019 May 16; Additional data on file.
