Unlike other biological and collagen-based scaffolds, the unique open polar configuration of TR Matrix™ exposes an “instruction manual” of natural amino acid sequences critical for regenerative wound healing. Host cells bind to TR Matrix™ and recognize these amino acid sequences resulting in activation of physiologic tissue repair.

Uses include treatment and repair of fractures, bone defects, delayed unions, osteotomies, non-unions, and arthrodeses. Available as a vial of 1 gram, shelf-stable, lyophilized powder.

TR Matrix™: TR Matrix™ is a structurally unique medical device that has multiple uses in veterinary medicine. TR Matrix™ is composed of a proprietary, non-immunogenic copolymer designed to mimic tertiary embryonic connective tissue and stimulate fetal-like repair mechanisms. TR Matrix™ does not contain any drugs, cells, or growth factors and achieves its tissue repair properties from a unique open polar structure.

BioScaffold Properties: The open polar structure of TR Matrix™ forms a scaffold to facilitate cell proliferation, differentiation, and integration. Assays have shown cells binding to TR Matrix™ will upregulate gene expression for a variety of factors, including Bone Morphogenic Protein 2 (BMP-2), Transforming Growth Factors ß3 & ß1 (TGF-ß3, TGF-ß1), Connective Tissue Growth Factor (CTGF), and aggrecan. These factors are consistent with cell in-growth, scarless tissue repair, extracellular matrix turnover and rapid and sustained vasculogenesis.

TR Matrix™ results in fetal-like wound repair, characterized by less fibrosis and contraction. The scaffold has been shown to alter the type of extracellular matrix produced; from a highly cross-linked, dense structure normally found in healed adult wounds to a more open reticular structure found in healed fetal wounds. Treated wounds have cells with “mesenchymoid” morphology with fewer differentiated myofibroblasts than typically seen in adult wounds, an effect consistent with fetal-like repair.

• Osteopromotive: Accelerates bone repair and osteogenesis
• Multi-Tissue Compatibility: Can be used in a variety of hard and soft tissues
• Non-Immunogenic: Designed for optimal tissue integration and acceptance
• Shelf-Stable: Safely utilized up to 1 year without refrigeration
• Cost-Effective: Allows use without limiting case selection
• Drug/Growth Factor Free: Optimizes performance by stimulating physiologic repair

Safety Summary: TR Matrix™ has undergone extensive preclinical safety studies including: ISO Acute Systemic Toxicity; ISO Acute Intracutaneous Reactivity; ISO Sensitization Study; Cytotoxicity Study (Agarose Overlay Model); Genotoxicity: Bacterial Reverse Mutation Study; Genotoxicity: Mouse Bone Marrow Micronucleus Study; Genotoxicity: Chromosomal Aberration Study in Mammalian Cells; and Safety Evaluation of Subcutaneously Injected Enhanced Matrix in the Rat. Studies indicated no significant local or systemic safety concerns.

Description of the Device: Sterile lyophilized gelatin-dextran copolymer bioscaffold.

How Supplied: 1 gram of sterile lyophilized gelatin-dextran copolymer bioscaffold in a 10 mL vial. (Note: The outside of the vial is NOT sterile.)

Handling: This is a SINGLE USE product and cannot be stored for additional use. Depending on the area being treated, TR Matrix™ can be used directly as a powder or mixed with sterile water, saline, or autologous fluids such as blood, serum, or bone marrow aspirate to achieve the desired consistency.

Intended Use of the Device:
Fractures: For use in canine, feline, and equine patients; indicated to serve as a scaffold for repair of fractures, bony defects, delayed unions, osteotomies, and non-unions.
Bone Graft Extender: The device may also be used as a cancellous bone graft extender.

Contraindications: Product should be discontinued if the condition worsens.

CAUTION: To be used by or under the supervision of a licensed veterinarian and is NOT intended for human application. If wounds are infected or compromised, then appropriate drainage and debridement is recommended prior to use.

PRECAUTIONS/WARNINGS: Inappropriate use may reduce efficacy. DO NOT microwave or autoclave the vials, or reuse the contents after re-solidifying. Each unit is intended for SINGLE USE; discard unused portions.

Storage: Store at room temperature in original packaging. Protect from direct light. The product should not be used beyond the expiration date.

Instructions for Use:
POWDER Application Instructions: Remove the plastic cap, aluminum overseal and rubber stopper.
Directly apply the contents into the lesion and pack in place to form a thick paste-like deposit.

PASTE Mixing Instructions: Remove the plastic cap, aluminum overseal and rubber stopper.
Incrementally add up to 5 mL of sterile water, saline or autologous fluids such as blood, serum or bone marrow aspirate to form a paste of desired consistency. This mixing can be done in the vial or a sterile bowl with a sterile spatula or other sterile flat instrument.

GEL Application Instructions:

Reconstitution of GEL:
• Remove the plastic cap; using sterile technique, wipe the rubber stopper with an alcohol swab.
• Using a sterile 18 gauge needle and plastic syringe, remove 5 mL of air then slowly inject 5 mL of sterile water or saline into the vial in an upright position.
• Heating: (a) submerge upright vial up to the aluminum overseal in warm water bath at 40°C (104°F) or (b) place vial in heating block that maintains a controlled temperature setting. DO NOT exceed 41°C (106°F).
• Heat until liquefied, approximately 20-30 minutes, but no longer than 90 minutes.
• Mix the liquefied GEL every 5 minutes by gently inverting vial 10 times (DO NOT shake).
• (NOTE: An additional 0.25mL of warm sterile water or saline may be added to decrease viscosity if necessary.)

Injection of the reconstituted GEL:

• Using sterile technique, wipe the rubber stopper with an alcohol swab.
• Using a sterile 18 gauge needle and plastic syringe, introduce approximately 3 mL of air into the vial and then withdraw the required volume of liquefied GEL into the syringe.
• Immediately inject or administer the liquefied GEL into the fracture site using an 18 or 20 gauge needle.

IMPORTANT:

• Replace the vial into the water bath or heating block after drawing up the gel into a syringe.
• Use reconstituted GEL within 90 minutes after heating. Do not re-heat or re-use if GEL solidifies.
• The GEL may solidify in the needle if not used quickly.
• Insure needle is patent before attempting to administer.

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