The information contained in this documentis intended for healthcare professionals only.

TissueMend®

Soft Tissue Repair Matrix

YOUR CHOICE FORTENDON AUGMENTATION

Rotator Cuff

Biceps

Quadriceps

Patellar

Achilles

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The TissueMend® Soft Tissue Repair Matrix is an acellular, collagenmembrane used to repair and reinforce soft tissues where weakness exists.

Composed of pure, non-denatured collagen, the TissueMend® SoftTissue Repair Matrix is indicated for tendon repair surgery, includingreinforcement of the rotator cuff, patellar, Achilles, biceps, quadriceps, orother tendons. TissueMend® can be used in both open & arthroscopicapplications.

The TissueMend® scaffold provides a biologic environment to help thetendon heal and fortify the tissue until it has completed the healingprocess.

What is the TissueMend® Soft Tissue Repair Matrix?

Composition Native, non-denatured, collagen

Collagen source Fetal bovine dermis

Appearance Flat, dry sheet of uniform thickness and color

Color White

Size 3 x 3cm, 4 x 4cm, 5 x 6cm, and 6 x 10cm

Pyrogens Non-Pyrogenic

Storage conditions Room temperature

Shelf life 3 years

Chemical crosslinkers None

Hydration Less than one minute

TissueMend® Product Specification

The Biologic Treatment of Choice for Tendon Augmentation

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The collagen fibers thatmake up the TissueMend®Soft Tissue Repair Matrixare not altered by artificialcrosslinking.

The acellular collagenfibers of the TissueMend®Soft Tissue Repair Matrixare composed primarilyof Type I and Type IIIcollagen fibers.

As a result of TissueMend®patented production process,all cells and cell componentsare removed from the sourcetissue while preserving thecollagen fiber structure.

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Collagen Scaffold

The human body uses collagen fibers as the predominant buildingmaterial for tissue and organs. The collagen fibers serve as the scaffoldwithin which cells grow, mature, and form new tissue.

Fetal Collagen

The source material used to produce TissueMend® is fetal bovine dermis. Studies in fetal wound healing havedemonstrated that fetal skin has remarkable regenerative capacities.1 Furthermore, fetal dermis contains minimalhair and hair follicles, which can cause imperfections in collagen structure.

1 Longaker, M.T.; Whitby, D.J.; Adzick, N.S.; Crombleholme, et al. Studies in Fetal Wound Healing, VI, Second and early third trimester fetal wounds demonstraterapid collagen deposition without scar formation. J. Pediatric Surgery, 25: 63-68, 1990.

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Host fibroblasts have migratedinto and populated TissueMend®beginning the remodeling process.

Note the lack of foreign bodyreaction to TissueMend®.Inflammatory cells are absentand the implant has not beenencapsulated.

Biological Response

When implanted, TissueMend® provides an environment that host cells andsupporting vasculature can take up residence and mature. Over time, normal tissueremodeling occurs where TissueMend® is incorporated into the native tissue andultimately replaced by natural, healthy, native cells and tissue.

Biocompatibility

The technologically advanced production process results in a highly biocompatible

implant. In standard biocompatibility assays, the TissueMend® Soft Tissue Repair

Matrix has been classified as a non-irritant.1

TissueMend®

Soft Tissue Repair Matrix

1. Data on file, TEI Biosciences Inc.

Three month rat intramuscular biocompatibility evaluation.

Endpoint Result

New tissue development A strong, robust connective tissue developed at the site of the soft tissue defect repaired with TissueMend®. The implant served as a scaffold upon and within which a new tissue developed. By 9 months, TissueMend® had been replaced by new, reparative tissue evident at both 9 and 15 months post-implantation.

Implant remodeling Acute (3 week) explants showed no gross evidence of remodeling. Histological examination revealed TissueMend® had been infiltrated with host cells and blood vessels. A new tissue layer was seen forming on the surface of the implant.

Long-term (9 and 15 month) explants from all animals revealed that TissueMend® had been remodeled into new, functional, host tissue.

Foreign body response No evidence of a foreign body response in any animal at any time point.

Surgical adhesions No surgical adhesions were observed to TissueMend®.

Study Results1

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Study Model

Species/Strain Sprague-Dawley rat

Surgical model Soft Tissue Repair Model

Incision was made along the abdominal midline of each animal

TissueMend®, extending approximately 1.5cm beyond the wound, was sutured into place along the perimeter of the implant to the underlying musculature

Time points 3 weeks

9 months

15 months

Endpoints New tissue development

Implant remodeling

Foreign body response

Surgical adhesions

1. Data on file, TEI Biosciences Inc.

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Early Histology

Histologic analysis of TissueMend®reveals incorporation of the implant.The matrix has been populated withhost cells and blood vessels. Newtissue is seen overgrowing theimplant.

Physical Appearance

Explanted TissueMend® implant hasbeen remodeled and replaced byrobust host connective tissue. Thesoft tissue defect is reinforced andrepaired.

TissueMend®

Soft Tissue Repair Matrix

Final Histology

• 15 month histology illustratescomplete remodeling ofTissueMend® implant.

• Fiber orientation has transformedfrom the random assembly seen inFigure 1 to the highly organized,parallel fibers seen in Figure 2.

• New tissue has completelyintegrated with host collagen atthe margin of the original defect.

Figure 1 3 week rodent model1

Figure 2 15 month rodent model1

Figure 3 9 month rodent model1

1. Data on file, TEI Biosciences Inc.

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Safety

TissueMend® has undergone and passed a thorough biocompatibility assessment conducted by an independent laboratory.1

TissueMend® ISO10993 Safety Profile

Test Test Method Result

Genotoxicity ISO10993-3 non-mutagenic

Hemolysis ISO10993-4 non-hemolytic

Cytotoxicity ISO10993-5 no evidence of causing cell lysis or toxicity

Implantation ISO10993-6 non-irritant

Intracutaneous Reactivity ISO10993-10 no evidence of significant irritation

Sensitization ISO10993-10 no evidence of causing delayed dermal contact sensitization

Acute Systemic Toxicity ISO10993-11 no mortality or evidence of systemic toxicity

Methods:

Validated terminal sterilizationprocess

Results:

Sterility assurance level (SAL) 10-6

Per regulatory requirements, the TissueMend® manufacturing process has been rigorously validated to assureproduct sterility and the inactivation of any potentially contaminating viruses. The source material has beencertified safe against the possibility of transmitting infectious transmissible spongiform encephalopathies.2

Sterility

Methods:

Validated viral chemicalinactivation manufacturing stepassures inactivation of potentiallycontaminated virus classes

• Enveloped RNA virus

• Enveloped DNA virus

• Non-enveloped RNA virus

• Non-enveloped DNA virus

Results:

Validated >6 log10 of viralreduction and clearance

Viral Inactivation

Methods:

Sourcing from fetal bovine dermis

Inspected and certified collection facilities

Results:

No detectable TSE infectivity in fetal tissue3

No detectable TSE infectivity in dermis3

European Directorate for the Quality ofMedicines (EDQM) TSE Safety CertificateR0-CEP 2004-116-Rev 00

Transmissible Spongiform Encephalopathies

1. Data on file, TEI Biosciences Inc.

2. European Directorate for the Quality of Medicines (EDQM) TSE safety Certificate R0-CEP 2004-116-Rev 00

3. Report of a WHO Consultation on Medical and Other Products in Relation to Human and Animal Transmissible Spongiform Encephalopathies - With the Participationof the Office International des Epizooties (OIE) - Geneva, Switzerland, 24-16 March 1997.

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TissueMend® is intended forreinforcement of soft tissuesrepaired by sutures or sutureanchors during tendon repairsurgery, including reinforcement ofthe rotator cuff, patellar, Achilles,biceps, quadriceps, or other tendon.TissueMend® was developed toovercome the challenges of tendonaugmentation surgery.

Factors such as poor tissue qualityand insufficient tendon length havecreated a need for physical andbiologic tendon augmentation.

By combining physical properties ofstrength and thickness withbiological properties that encouragecell and blood vessel penetration, theTissueMend® collagen matrix isdesigned to handle the demands ofsoft tissue repair.

Indications:

TissueMend®

Soft Tissue Repair Matrix

Rotator Cuff Biceps

Quadriceps Patellar

Achilles

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Strength and Thickness:

• TissueMend® is composed of a singlelayer of nondenatured collagen fibers.

• TissueMend® is nominally 1mm thick.

• Suture pull out strength ofTissueMend®: 35.5 N.1

HydrationThe TissueMend® collagen matrix hydrates in only seconds, thus reducingwait time and enhancing efficiency in the operating room.

StorageTissueMend® does not require refrigeration. TissueMend® may be stored on the shelves of any hospital or operatingroom for up to 3 years.1

TissueMend®

#2, non-resorbable suturesingle stitch, mattress technique

10 lb weight

1. Data on file, TEI Biosciences Inc.

Non-hydrated Hydrated Hydrated

Strength and Handling

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Soft Tissue Repair MatrixTissueMend®

What is TissueMend®?

How does TissueMend® work?

What features does TissueMend® display?

• The TissueMend® Soft Tissue Repair Matrix is an acellular, collagenmembrane used to reinforce soft tissues where weakness exists.

• TissueMend® is composed of pure, non-denatured collagen and is foraugmentation of tendon repair surgery.

• For today's challenging tendon repair surgery, surgeons need a strong,suturable, collagen fiber scaffold to augment the repair both physicallyand biologically.

• Like a soft tissue autograft or allograft, TissueMend® is specificallydesigned to serve as a scaffold for cellular and vascular ingrowth thatis gradually remodeled into new tissue.

• Strength: 20.0 MPa

• Suture Pull Out: 35.5 N

• Handling & Physical Characteristics: Allows both open &arthroscopic applications

• Hydration: Less than 1 minute

• Storage: Room temperature

• Shelf Life: 3 years

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The information presented in this brochure is intended to demonstrate the breadth of Stryker product offerings. Always referto the package insert, product label and/or user instructions before using any Stryker product. Surgeons must always rely ontheir own clinical judgment when deciding which treatments and procedures to use with patients. Products may not beavailable in all markets. Product availability is subject to the regulatory or medical practices that govern individual markets.Please contact your Stryker representative if you have questions about the availability of Stryker products in your area.

Products referenced with TM designation are trademarks of Stryker.Products referenced with ® designation are registered trademarks of Stryker.TissueMend is a registered trademark of TEI Biosciences Inc.

Literature Number: LTMEIBMS/GS 3m 01/06

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