Tactoset® Injectable Bone Substitute 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.® Injectable Bone Substitute

• Bone voids, also known as bone marrow lesions (BMLs), represent focal edema in the subchondral bone1 • Causes include trauma, insufficiency fractures, degenerative cartilage lesions1 • BMLs have been linked with significant pain, cartilage degeneration and the progression of osteoarthritis2,3 • Studies have shown that BMLs are associated with an increased risk of total knee replacement3,4 • X-rays are commonly used to determine severity of osteoarthritis, however BMLs cannot be detected on X-ray2 BMLs can be identified on fluid sensitive, fat suppressed magnetic resonance imaging (MRI) 12 Recognized...

Technology overview • Calcium phosphate injectable, self setting, osteoconductive biocompatible bone graft substitute material intended for permanent implantation5,6 Indicated for filling bone voids or defects of the skeletal system that are not intrinsic to the stability of bony structure, such as surgically created osseous defects or defects created from traumatic injury to the bone5 Can be mixed with autogenous bone marrow aspirate (BMA) Hardens post deployment to reinforce weaknesses such as those created by bone voids6 Converts to a poorly crystalline hydroxyapatite at body temperature5...

Hardware Augmentation Augmenting with Tactoset drives surgical confidence • Tactoset is indicated for augmentation of hardware such as soft tissue anchors5 Increases the density of poor-quality bone caused by cysts or osteoarthritis, resulting in additional suture anchor pullout strength11 Allows for placement of anchors in the ideal repair location, eliminating the need for extra anchors or complex techniques Augmenting anchors with Tactoset was shown to significantly increase pullout strength and stiffness in osteoporotic bone models11 Representation of anchor augmented with Tactoset within...

ComponentsTactoset material set1. Pre-filled mixing syringe containing powder containing setting solution Luer lock syringes Luer lock connector (with removable drillable stylet) GAUGE: 3.05 mm (11 Ga) LENGTH: 110 mm for end delivery GAUGE: 2.41 mm (13 Ga) LENGTH: 134.39 mm for side delivery GAUGE: 2.41 mm (13 Ga) LENGTH: 134.39 mm Anika delivery cannulas provide easier use with mini c-arm

• Contains hyaluronic acid (HA), a naturally occurring substance in the human body7 • HA enhances delivery of the calcium phosphate • Highly flowable and easily injectable through minimally invasive surgery6 • Provides tactile feedback to confirm filling of the bone defect6 • Interdigitates into trabecular bone architecture to fill closed bone voids56 • Enhances ease of use: no mixing bowls; no mess6 • Allows surgeons to easily switch intraoperatively between side and end Tactoset delivery without having to remove and reinsert the outer cannula6 Tactoset® Injectable Bone Substitute

Mixing Instructions Hydration of Tactoset powder5 Step 1 | Unpacking • Open packaging and transfer contents to the sterile field using sterile technique. Loosen stopper on each 1 mL syringe by pulling plunger rod back slightly to break seal. Remove the cap from the prefilled mixing syringe containing the powder (do not discard). • Remove the cap from the glass syringe. Note: If mixing with BMA, see instructions for use or visit www.anikaifu.com before proceeding to the next step. • Using a female-female Luer lock connector, attach the glass syringe containing the setting solution to the mixing...

Step 4 | Loading injection syringes • Reattach the plunger rod sleeve over the integrated mixing handle • Remove tip cap and attach a Luer lock connector to the mixing sgringe. Expel residual air from the mixing sgringe until a smalt drop of Tactoset is ejected. • Attach a 1 mL Luer lock syringe. Hold and pull back on the plunger rod of the 1 ml_ sgringe to aid in transferring Tactoset material. Fill to 0.9 mL. Do not overfill. Note: For complete product information, see instructions for use or visit www.anikaifu.com Start timer as soon as powder and setting solution make contact • Mix powder...

Preoperative planning • Utilize appropriate magnetic resonance imaging (MRI) sequences across all 3 planes (axial, coronal, sagittal) to identify the precise location of the bone void Operating room setup • Place the patient on a radiolucent table in the supine position • Elevate the operative leg to a position that allows for unobstructed radiographic views during the procedure • Ensure access to standard arthroscopic instruments and preoperative MRI images throughout the procedure • Obtain appropriate fluoroscopic views to visualize the bone void • Determine preferred trajectory to access the...

Shoulder Surgical Technique • Using a spinal needle percutaneously, identify the desired point of anchor placement most proximal to the affected bone. Take care to use a perpendicular approach in relation to the cortical surface to ensure proper drilling trajectory Make a small stab incision at the needle site for the 11Ga Tactoset cannula placement Under power, drill the 11Ga cannula to the approximate depth of the selected anchor using the laser lines as guidance. Avoid multiple drill attempts as this could result in extravasation of the material Left shoulder, anterior view: cyst shows up...

Preclinical Data Study purpose and design6 Evaluate the in vivo performance of Tactoset in a critical size defect of the distal femoral condyle in skeletally mature female New Zealand White Rabbits. Bilateral defects, 6-mm in diameter and 10-mm deep, were created in cancellous bone of the right and left femora and Tactoset was implanted. Histology Results PMMA Histology Tactoset Time 0 The scale bar in these images is 1 mm The implant is well placed within the defect. Tactoset is present in the defect with new bone on-growth directly on the material. No fibrous interface was seen. No adverse...