Anika Therapeutics, Inc. 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. In an independent head-to-head animal study 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 mapped 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 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 launch of Integrity continues Anika's release of differentiated products to support shoulder surgeons and a portfolio built around rotator cuff disease. Integrity, combined with recent product launches including X-Twist?? Fixation System, RevoMotion??

Reverse Total Arthroplasty System, and Tactoset®? Injectable Bone Substitute for hardware augmentation, provide a truly innovative and comprehensive rotator cuff solution portfolio that is unmatched in the industry. The Company's actual results could differ materially from any anticipated future results, performance, or achievements described in the forward-looking statements as a result of a number of factors including, but not limited to, the Company's ability to successfully commence and/or complete clinical trials of its products on a timely basis or at all; the Company's ability to obtain pre-clinical or clinical data to support domestic and international pre-market approval applications, 510(k) applications, or new drug applications, or to timely file and receive FDA or other regulatory approvals or clearances of its products; (iii) that such approvals will not be obtained in a timely manner or without the need for additional clinical trials, other testing or regulatory submissions, as applicable; (iv) the Company's research and product development efforts and their relative success, including whether have any meaningful sales of any new products resulti ng from such efforts; (v) the cost effectiveness and efficiency of the Company's clinical studies, manufacturing studies, manufacturing, and other regulatory approvals or clearances.