Integrity™ Implant System Value Analysis Committee Brochure

Anika is a global joint preservation company that creates and delivers meaningful advancements in early intervention orthopedic care. We partner with clinicians to understand what they need most to treat their patients and we develop minimally invasive products that restore active living for people around the world. We are committed to leading in high opportunity spaces within orthopedics, including osteoarthritis pain management, regenerative solutions, sports medicine, and Arthrosurface. Anika. Restore Active Living.® Integrity™ Implant System

The Anika Integrity Implant is a synthetic scaffold for rotator cuff repair that provides reliable strength, regenerative biology and a streamlined, precise technique • Integrity provides higher tensile strength, suture retention, and tear resistance in a thin knitted format1 • Inherently strong scaffold can be confidently manipulated arthroscopically and enables surgical versatility Regenerative biology • Hyaluronic acid-based scaffold supports healing through improved cell infiltration, tissue remodeling, and tendon thickening • Porous, flexible construct knitted using HYAFF®, Anika's proven...

Anika's Integrity Implant is a porous, knitted scaffold constructed of Anika's HYAFF® material, a proven hyaluronic acid technology that supports tissue regeneration and resorbs over time, reinforced with non-absorbable PET (polyethylene terephthalate). • Benzyl ester modified derivative of hyaluronic acid (HA), a naturally occurring substance in the body • Hydrophobic properties allow for good cell adhesion and viability • Increased residence time in vivo compared to native HA • Once HYAFF degrades releasing HA, it is naturally resorbed into the body5 • HA is a natural and major component of...

Biological Role of Endogenous Hyaluronic AcidAt a Cellular Level • Endogenous hyaluronic acid (HA) is the main ligand for CD44 receptors to regulate specific cell types to modulate inflammation and healing • Involves morphogenesis (the shaping of organisms by the embryological process of differentiation of cells and tissues)9 • Promotes cell proliferation through activation of TGF-|3/BMP signaling10 • Helps in the growth and development of new cells and tissues, and repairing injured cells and tissues8 • Binds to water, creating a viscous fluid that provides lubrication and serves as a shock...

Integrity demonstrated: tensile strength suture retention strength Tensile Strength Integrity Suture Retention Tear Resistance Market-leading collagen implant All samples hydrated. Porosity A porous structure optimizes the interaction between the implant and the native cells to aid in the tissue regeneration process. At 100x magnification, the Integrity Implant exhibits excellent porosity.11 Scanning electron microscope (SEM) image. 100x magnification

Components Integrity Implant System Overview Tissue Tack Delivery Instrument Fixation Caddy Bone Staple Delivery Instrument Integrity Implant Bone Staple Bone Staple Open Caddy Integrity™ Implant System

Integrity ImplantStructure iRHHHir Flexible knitted structure provides additional: • Tensile/shear strength • Tear resistance • Suture retention strength • Lock stitch construction with laser-cut edge • Thick, blue borders for orientation

One-way fixation fins Material • PEEK (polyether ether ketone) • Reinforced shaft for rigidity • Dual shaft: exit point for sharp tines from bone delivery tool • Provide multiple tissue fixation points • Sixteen fins per bone staple • Two bone staples per caddy Material • PLGA: Poly(lactic-co-glycolic acid) • Effective resorption in 6-12 months • Reinforced shaft for rigidity • Single shaft: exit point for sharp tine from tissue tack delivery tool • Multiple tissue fixation points • Proximal end: triangular fixation via three hooks • Three perimeter distal fins • Six 7mm tissue tacks per caddy...

Surgical Technique Approaches The Integrity Implant is a medical device intended for the management and protection of tendon injuries such as the rotator cuff and Achilles tendon. The implant can be confidently manipulated in situ, is easy to handle, porous, and pliable in both the dry and hydrated state. An arthroscopic or open approach may be used. If arthroscopic, a single portal or dual portal may be utilized. If open, the surgeon may use an all-suture technique to secure the Integrity Implant to the injured tendon. Dual Portal Simplified Rotator Cuff Surgical Technique: 1. Place lateral...

Preclinical Data Study Objective To characterize bone ingrowth, local tissues response, and biomechanical effectiveness of repair of the rotator cuff with Anika’s Integrity Implant test group using an overlay technique compared to the leading competitive commercially available collagen device. interactions with host tissue in different sites and is applicable to use in humans. The products tested were Anika’s Integrity Implant, the market-leading collagen implant and a control group (which had an injury but no implant). Time points were taken at 6, 12, and 26 An ovine model was chosen for this...

* Indicates improved cellular response in internal studies as compared to REGENETEN ** Surgeon perception of mixed clinical results, higher failure rates and tissue limitations like strength and propensity to stretch (SmartTrak 2023)

Note: It is the provider's responsibility to determine and submit appropriate codes for services that are rendered. This information is meant as a reference and should not be interpreted as providing clinical advice, dictating reimbursement policy, or substituting for the judgment of a practitioner. Reimbursement laws, regulations, and payor policies change frequently, therefore, it is recommended that providers consult with their payors, coding specialists, and/or legal counsel regarding coverage, coding and payment issues. Potential procedure codes include: Integrity™ Implant System