Anika Announces First Surgeries Performed using the Integrity Implant System, a Regenerative Hyaluronic Acid-Based Patch System for Rotator Cuff Repairs, Commencing Limited Market Release

Integrity marks Anika’s entrance into the fast-growing $150 million+² U.S. rotator cuff augmentation market and expansion of its proprietary hyaluronic acid (HA) regenerative portfolio

BEDFORD, Mass., Nov. 28, 2023 (GLOBE NEWSWIRE) -- Anika Therapeutics, Inc. (NASDAQ: ANIK), a global joint preservation company focused on early intervention orthopedics, today announced that the first surgeries using the Integrity Implant System were successfully performed by Dr. Christopher Baker at the Florida Orthopaedic Institute in Tampa, FL. Integrity, comprised of a hyaluronic acid-based scaffold with bone and tendon fixation components and single use arthroscopic delivery instruments, is designed to protect an injured tendon and promote healing in rotator cuff repair and other tendon procedures. The system was fully cleared by the FDA in August of 2023. This marks the beginning of the limited U.S. market release ahead of schedule that will ramp to a full market release during the first quarter of 2024.

“The successful first surgeries using Anika’s new Integrity Implant System mark another key milestone in the build out of our regenerative product portfolio as we continue to provide differentiated solutions to surgeons for rotator cuff procedures,” said Cheryl R. Blanchard, Ph.D., Anika’s President and CEO. “The HA-based scaffold, together with the instrumentation and fixation components, provide a seamless, efficient, and elegant rotator cuff repair solution. While having a strong implant at time zero is critically important in rotator cuff repairs, the instrumentation and delivery are just as important, and we believe we have nailed it. The feedback received after the procedure exceeded our expectations highlighting the system’s ease of use and strength of the HA-based scaffold. We believe that Integrity is truly a game changer for surgeons and their patients and look forward to extending this exciting technology to other tendon repairs, for example, in the foot and ankle.”   

The Integrity implant itself is a flexible, knitted, HA-based scaffold that provides improved dry and wet strength and regenerative capacity over first generation collagen patches¹, and supports regenerative healing through improved cell infiltration¹, tissue remodeling¹, and tendon thickening¹. In an independent head-to-head animal study¹ comparing Anika’s Integrity system and the market leading collagen implant, fibroblast infiltration and regularly oriented new collagenous tissue formation had occurred within the Integrity repair, demonstrating greater regenerative capacity as early as 12 weeks post-implantation. At 26 weeks, within the resorbing Integrity structure, new collagenous tissue infiltration had occurred, forming a new network of tendon tissue. This resulted in an average repaired tendon thickness nearly three times greater than with the market-leading collagen device. The scaffold component of the Integrity system is a porous, knitted, flexible construct combining Anika’s proprietary HYAFF fibers with polyethylene terephthalate (PET) and is designed to support cell infiltration and regenerative healing. Integrity is inherently strong and can be confidently manipulated arthroscopically, which offers a truly unique and differentiated solution for shoulder surgeons to treat rotator cuff tears. Integrity is fixated using PEEK bone staples, resorbable PLGA soft tissue tendon tacks or suture fixation, as desired, at the site of the rotator cuff repair. The fixation components and instrumentation are delivered single-use and sterile for added efficiency.