BIOFIBER. Absorbable Biologic Scaffolding Solutions

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1 BIOFIBER Absorbable Biologic Scaffolding Solutions

2 BIOFIBER IS ONLY THE BEGINNING BIOFIBER - CM What is BIOFIBER CM? BIOFIBER Collagen Matrix is comprised of the same P4HB material with the addition of a type 1 bovine collagen coating which increases vascularization and cell density at the site of repair. Provides long-term support while serving as a biocompatible scaffold for host tissue in-growth Distributes tissue loads during the healing process while allowing for return of natural tendon attachment to bone Provides support during healing to permit return to normal joint mechanics Designed to provide support to damaged soft tissue to maintain structural integrity

3 Reinforces the suture-tendon interface What is BIOFIBER? An advancement in orthopedic absorbable polymers, BIOFIBER is the first orthopedic soft tissue scaffold that: Reinforces the suture-tendon interface Mechanically reinforces tendons repairs Made from P4HB A non-synthetic fermented polymer that breaks down into natural occurring metabolites that allow healing without additional inflammation Increases suture line load sharing Creates a cell friendly environment for rapid incorporation of soft tissue Humeral Bone Tendon BIOFIBER BIOFIBER is woven out of a high-strength, biologically derived material that resorbs over time. Designed for tissue in-growth utilizing an improved biocompatible polymer Creates a cell-friendly environment for rapid incorporation of soft tissue with full scaffold resorption at months Tendon Tendon in-growth within scaffold

4 STRENGTHEN REPAIRS High tensile and suture retention strength Resorbable, biologically derived fiber Dense, bi-layer weave designed to provide mechanical properties in all directions Ability to wick and hold blood Why Reinforce? High failure rates for older patients or patients with thin, weak tendons High failure rates for larger tears Patients with comorbid conditions Suture line tears Tissue that forms post repair is mechanically weaker than native tissue Suture Retention Strength (N) BioFiber Reinforced Tendon: 73% Increase in Suture Retention vs. Control 65.1 Control BIOFIBER Average suture retention strength for BIOFIBER reinforced tendons was 110 N and the control tendons were 65 N which is an increase of 73 ± 37% (p < ) Suture Retention** 229 GraftJacket MaxForce Extreme 216 BIOFIBER * 182 GraftJacket MaxForce Data on file at Tornier, Inc. Barber, A. et al. Tendon augmentation grafts: biomechanical failure loads and failure patterns. Arthroscopy: The Journal of Arthroscopic and Related Surgery. 2006; 22-5: * BIOFIBER (3 cm x 3 cm) ** Mattress stitch 5 mm or more from an edge

5 Special leno weave designed to prevent fraying High strength yet elastic to share the load with in-growing tissue Edges ultrasonically cut for strength and consistency Porous design to encourage tissue in-growth Biomechanical Reinforcement Overlay Grommet support Mid-substance reinforcement BIOFIBER Applications BIOFIBER is available in multiple shapes and sizes which allows for a wide range of indications and repairs using a simple and fast surgical technique. Shoulder Rotator cuff repair Small tears Medium tears Subscapularis repair Foot/Ankle Achilles tendon repair Retrocalcaneal enthesiopathy Lateral ankle instability Knee Quadriceps tendon repair Patellar tendon repair Hip Hip abductor tendon repair

6 BIOFIBER Product Codes Product Item No. Product Description Discs: 8 mm each (2 discs/unit box) BFR Box of 1 BBF0008DU Box of 4 Strips: 13 mm x 23 mm (1 strip/unit box) BFR Box of 1 BBF1323SU Box of 4 BIOFIBER Facility Reimbursement HCPCS Code Hospital Q4100 Skin substitute, not otherwise specified HCPCS Code Ambulatory Surgery Center L8699 Prosthetic implant, not otherwise specified Strips: 20 mm x 30 mm (1 strip/unit box) BFR Box of 1 Strips: 25 mm x 50 mm (1 strip/unit box) BFR Box of 1 BIOFIBER - CM Product Codes Product Item No. Product Description Strips: 20 mm x 30 mm (1 strip/unit box) BFR Box of 1 Indications: Temporary wound support required to reinforce soft tissues where weakness exists or for the repair of hernia or other fascial defects that require the addition of a reinforcing material to obtain the desired surgical result. Reinforcement of soft tissues, in conjunction with sutures and/or suture anchors during tendon repair surgery; including the reinforcement of rotator cuff, patellar, achilles, biceps and quadriceps tendons. BioFiber is intended for single patient, one time use only BioFiber is not intended for use as a replacement for normal body structures or to provide the full mechanical strength to support structures. Contraindications: A complete list of contraindications can be found in the instructions for use packaged with the implants Cherry Road Memphis, TN Nesbitt Avenue South Bloomington, MN BIOFIBER is a trademark or registered trademark of Tornier in the U. S. and other countries. Trademarks and Registered marks of Wright Medical Technology, Inc Wright Medical Technology, Inc. All Rights Reserved. CAW-5601 Rev B ECN Jan-2016