BEDFORD -
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
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.
The
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This press release may contain forward-looking statements, within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, concerning the Company's expectations, anticipations, intentions, beliefs or strategies regarding the future which are not statements of historical fact, including statements regarding the planned launch and future expansion of Integrity, the potential expansion of Integrity to treat other tendon repairs, and the potential growth of the rotator cuff augmentation market. These statements are based upon the current beliefs and expectations of the Company's management and are subject to significant risks, uncertainties, and other factors. 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, (i) the Company's ability to successfully commence and/or complete clinical trials of its products on a timely basis or at all; (ii) 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 we have any meaningful sales of any new products resulting from such efforts; (v) the cost effectiveness and efficiency of the Company's clinical studies, manufacturing operations, and production planning; (vi) the strength of the economies in which the Company operates or will be operating, as well as the political stability of any of those geographic areas; (vii) future determinations by the Company to allocate resources to products and in directions not presently contemplated; (viii) the Company's ability to successfully commercialize its products, in the
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