Complete Integrity Implant System is now fully cleared; targeting launch in Q1-2024

Integrity is highly differentiated by its knitted structure, resulting in higher strength and greater regenerative capacity compared to first generation bovine collagen patches¹

Integrity marks Anika’s expansion of its proprietary regenerative portfolio and entrance into the over $150 million² U.S. rotator cuff augmentation market

The Integrity implant is a flexible, knitted, HA-based scaffold that provides improved strength and regenerative capacity over first generation collagen patches¹, and supports regenerative healing through improved cell infiltration¹, tissue remodeling¹, and tendon thickening¹.

“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, Ph.D., Anika’s 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. The HA-based patch, together with the instrumentation and fixation, provide a seamless, efficient, and elegant rotator cuff repair solution. This clearance opens significant opportunities in the shoulder and we see future expansion for this innovative technology in other anatomies. Integrity enhances the breadth and depth of our regenerative offering, adding critical mass to a growing portfolio that provides meaningful solutions to unmet needs in early intervention orthopedics that restore active living for patients around the world.”

The Integrity Implant System is comprised of the HA-based patch implant, fixation implants, and single use arthroscopic delivery instruments. The patch component of the system is a porous, flexible construct knitted using HYAFF^® fibers and designed to support cell infiltration and regenerative healing. HYAFF is Anika’s proven and proprietary esterified HA technology that resorbs over time as tissue remodels. 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. The Integrity patch implant is fixed using PEEK bone staples, resorbable PLGA soft tissue tendon tacks, or suture fixation, as desired, at the site of the rotator cuff augmentation. The fixation components and instrumentation are delivered single use and sterile for added efficiency.

Christopher Baker, MD, of the Florida Orthopedic Institute commented, “I’m excited to see Anika working to improve the biologic augmentation market starting with rotator cuff repair. While some collagen products on the market are showing promising results with biological incorporation, in animal studies, Integrity facilitated improved biological healing without the use of animal collagen, while also providing a scaffold that can add strength to the construct at the time of implantation. In addition to improving the patch itself, they have also identified a more streamlined surgical technique. This product could improve patient outcomes and reduce the likelihood of future failures of rotator cuff repair.”

In an independent head-to-head animal study comparing Anika’s Integrity system and the leading competitive collagen device, 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 forming a new network of tendon tissue had occurred. This resulted in the repaired tendon thickness being nearly 3 times greater than with the competitive collagen device. Tendon thickness is thought to improve the local biomechanical environment of the tear by reducing tendon strain, thus optimizing it’s healing potential³.

Timothy Codd, MD, of the University of Maryland St. Joseph Medical Center stated, “Building on previous work with biological augmentation, the new Integrity system will be the next step forward in improving tendon healing and patient outcomes, with refined and more precise delivery. With the ability to augment and improve tendon healing along with increased structural support for early tendon repairs, Integrity should be the next big advance in improving patient outcomes in rotator cuff disease.”

The U.S. rotator cuff augmentation market is currently estimated at $150 million², growing at a nearly 7% CAGR² over the next 5-years, representing one of the high opportunity spaces in orthopedics. The Integrity Implant System continues Anika’s focus on delivering new, differentiated shoulder solutions, with a specific focus on the intersection of regenerative solutions and sports medicine. The Integrity clearance, and upcoming launch, continues Anika’s release of unique products to support shoulder surgeons and a portfolio built around rotator cuff disease. Recent launches include Tactoset with hardware augmentation and with bone marrow aspirate, the X-Twist suture anchor fixation system, and the RevoMotion Reverse Shoulder System. These new products allow Anika to expand deeper into the shoulder market by offering regenerative, sports medicine, and reconstructive solutions.

Anika expects to commence a limited market release of Integrity in the United States in the first quarter of 2024 with a full U.S. market release and expansion into international markets to follow.