Anika Therapeutics, Inc. is one important step closer to FDA approval of its novel hyaluronic acid (HA) matrix, single-stage, bone-preserving, regenerative knee cartilage repair product.
This leader in early intervention joint preservation technologies, announced this week that researchers had completed a pivotal Phase III clinical study for its knee cartilage repair product, HyaloFast® (HyaloFast 15-01).
Streamlining Knee Cartilage Repair
Anika’s HA matrix product is a single step treatment for degenerative knee cartilage repair. That is unlike the current standard of care, which involves multiple surgeries and the removal of autologous cartilage. By contrast, Anika’s HyaloFast 15-01 can be implanted, following the removal of diseased tissue, in a single intervention—without the need for additional procedures or the removal of healthy bone.
This streamlined approach reduces patient burden and healthcare costs. Additionally, Anika’s HyaloFast is an off-the-shelf item. Ready, in other words, whenever a surgeon identifies a cartilage lesion during surgery.
Anika’s President and CEO, Cheryl R. Blanchard, Ph.D., emphasized to OTW the significant market potential and alignment with Anika’s strategic focus on introducing groundbreaking regenerative solutions. Blanchard believes that HyaloFast will drive market expansion and further accelerate the company’s growth in the coming years. She also highlighted the fact that the FDA granted Breakthrough Device Designation for HyaloFast and the agreement for a modular Premarket Approval (PMA) filing, both of which will expedite the review process.
International Success of HyaloFast®
HyaloFast is already being marketed in over 35 countries worldwide and has demonstrated, according to Anika, efficacy in medium to long-term follow-up studies. In those studies, said the company, patients consistently report pain reduction and improved joint function, leading to a return to their active lifestyles. The off-the-shelf, bone-preserving design of HyaloFast allows surgeons to repair lesions during surgery without the need for a second invasive procedure.
Since its introduction in 2009, said Anika, HyaloFast has exhibited a strong safety profile.
FDA Breakthrough Device Designation
The FDA has granted Anika Breakthrough Device Designation for HyaloFast in combination with autologous bone marrow aspirate concentrate (BMAC). This designation allows Anika to engage with the FDA on a prioritized basis, expediting the review process and facilitating faster access to new therapies for patients. Anika also expects to file a modular PMA submission, enabling the company to provide product and manufacturing information while collecting and analyzing clinical data concurrently.
Anika’s Regenerative Portfolio
Upon FDA approval, HyaloFast will join Tactoset® Injectable Bone Substitute in Anika’s regenerative portfolio. Anika is actively developing other products, including an HA-based arthroscopic patch system, to further expand its Joint Preservation and Restoration offerings. Tactoset is a biocompatible bone graft substitute that enhances handling characteristics and is widely used in the treatment of insufficiency fractures, as well as for the augmentation of hardware.
About HyaloFast: HyaloFast is a biodegradable, non-woven scaffold composed of HYAFF® fibers, Anika’s proprietary solid form of hyaluronic acid (HA). It is designed to support the entrapment of mesenchymal cells in cartilage.
