Anika Therapeutics (Nasdaq:ANIK) announced that it received the final FDA 510(k) clearance for its Integrity implant system.
Bedford, Massachusetts-based Anika designed Integrity to augment an injured tendon, promoting healing in rotator cuff repair procedures. This clearance for the hyaluronic acid (HA)-based patch component joins previous clearances for associated fixation devices and instruments.
The company describes Integrity as a flexible, knitted, HA-based scaffold. It provides improved strength and regenerative capacity compared to first-generation collagen patches. The implant supports regenerative healing through improved cell infiltration, tissue remodeling and tendon thickening.
“The clearance of Integrity is a key milestone in the continued build-out of Anika’s proprietary HA-based regenerative portfolio and underscores our commitment to helping surgeons improve outcomes in rotator cuff repair procedures through biologic healing,” said Cheryl R. Blanchard, Anika president and CEO. “Integrity, named for its structural integrity compared with first-generation collagen patches, is a key value driver for Anika and was developed internally using our proprietary HA technology that has demonstrated differentiated regenerative performance characteristics.”
Blanchard added that the clearance “opens significant opportunities” in the shoulder, plus for expansion in other anatomies.
More about the Anika Integrity system
Integrity features the HA-based patch implant, fixation implants and single-use arthroscopic delivery instruments. The patch, comprised of porous, flexible construct knitted using HYAFF fibers, supports cell infiltration and regenerative healing. HYAFF, Anika’s HA technology, resorbs over time as tissue remodels.
Anika says surgeons can manipulate Integrity arthroscopically, offering a unique and differentiated solution for treating rotator cuff tears. Surgeons fix the implant using PEEK bone staples, resorbable PLGA soft tissue tendon tacks or suture fixation.
The company cited support from an independent head-to-head animal study comparing Integrity and a leading competitive collagen device. In the study, fibroblast infiltration and regularly oriented collagenous tissue formation occurred within the Integrity repair. This demonstrated greater regenerative capacity as early as 12 weeks post-implant.
At 26 weeks, within the Integrity structure, new collagenous tissue infiltration formed a new network of tendon tissue. Anika said this resulted in nearly three-times greater repaired tendon thickness compared to the competitor.
The company expects to begin a limited market release of Integrity in the U.S. in the first quarter of 2024. It plans to follow this with a full U.S. market release, plus expansion into international markets.
