LIG

AM

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IT

Ligament Tool Kit Table of Contents

1. Products a. Allograft Tissue Package Insert b. The “Ligamentization” Process in Human Anterior Cruciate Ligament Reconstruction with

Autogenous Patellar and Hamstring Tendons: A Biochemical Study, Marumo et al. c. Allograft Compared with Autograft Infection Rates in Primary Anterior Cruciate Ligament

Reconstruction, Greenberg et al. d. A Systematic Review of Anterior Cruciate Ligament Reconstruction with Autograft Compared

with Allograft, Carey et al.

A. BTB

i. BTB Overview

B. BTB Select

ii. BTB Select Overview iii. Bone Block Comparison Card iv. BTB Select Technique Guide

C. Achilles

v. Achilles Overview vi. Achilles Allograft Use in Anterior Cruciate Ligament Reconstruction, Indelicato

D. Non-Bone Tendons

vii. Non-Bone Tendon Overview viii. Tendon Comparison Overview ix. The Clinical Use of a Four-Stranded Peroneus Longus Allograft in Anterior Cruciate

Ligament Reconstruction, Milia x. Anatomic Double-Bundle Anterior Cruciate Ligament Allograft Reconstruction, Tejwani xi. Analysis of the Biomechanical Properties of Peroneus Longus Tendons Sterilized with

BioCleanse, Pedroso & Zhukauskas 2. Allograft Processing

a. FAQ’s and Handling Objections - Processing b. Clostridium Infections Associated with Musculoskeletal-Tissue Allografts, Kainer et al. c. Allograft Update: The Current Status of Tissue Regulation, Procurement, Processing, and

Sterilization, McAllister, et al. d. Nonirradiated Versus Irradiated Achilles Autograft: In Vivo Failure Comparison, Rappe et al. e. Effects of a Novel Sterilization Process on Soft Tissue Mechanical Properties for Anterior

Cruciate Ligament Allografts, Schimizzi et al. f. Mechanical Properties of Patellar Tendon Allografts Subjected to Chemical Sterilization, Jones,

et al.

g. Anterior Cruciate Ligament Reconstruction with BPTB Autograft, Irradiated Versus Non-Irradiated Allograft: A Prospective Randomized Clinical Study, Sun, et al.

A. BioCleanse®

i. BioCleanse® Elevator Statement ii. Proven Campaign Flyer iii. Proven Campaign: Myth vs. Fact iv. Sports Medicine Patient Brochure v. Allograft Quality Assurance Overview vi. BioCleanse Tissue Sterilization Process Fact Sheet vii. Evaluation of the Sterilization Potential of the BioCleanse Tissue Sterilization Process,

Roberts, et al. viii. Dye Perfusion Into Cadaveric Human Bone as an Indication of Sterilant Penetration,

Roberts et al. ix. Method to Determine Germicidal Inactivation in Allograft Processing, Mills, et al. x. Mechanical Testing of BioCleanse Soft Tissue Allografts, Carr et al.

3. Age a. National Death and Donor Statistics b. Effect of Age on the Mechanical Properties of Human Anterior Tibialis Tendons Sterilized

Through the BioCleanse Process, Pedroso & Myrick

4. Specifications

a. Ligament Reconstruction: Product Label Measurements b. FAQ’s & Handling Objections – Specs c. Avoiding Allograft Length Mismatch during Anterior Cruciate Ligament Reconstruction, Brown et

al. d. “Hybrid” Single-Bundle Anterior Cruciate Ligament Reconstruction: Quadrupled Hamstring

Autograft Combined With Tibialis Anterior Allograft, Tejwani

5. Fees

a. FAQ’s & Handling Objections – Fees b. 2011 RTI List Fees c. AlloSource catalogue d. BioMet Fees e. LifeLink Fees f. LifeNet Fees g. MTF Fees

products

AcHILLEs

products

PROVEN Sterilization without Irradiation

Achilles Tendons

Achilles tendons allow for multiple techniques and fixation options in ligament reconstruction procedures. Achilles tendons distributed by RTI Biologics are sterilized without the use of irradiation through the patented BioCleanse® Tissue Sterilization Process, which inactivates or removes potential pathogens while maintaining the tissue’s biomechanical properties.

Achilles Tendon Options:

Pre-Shaped

Pre-Trimmed

Conventional

Achilles Tendon Benefits

• Allowsformultiplefixationtechniques

• Minimizes operating time and simplifiessurgical technique as compared to autograft

• Eliminatesdonorsitemorbidity

• Multipleboneblockoptionsallowthesurgeonto shape the graft into desired form and size at time of surgery

Pre-Shaped Benefits

• Naturalcalcaneusboneblockallowsformultiplefixationtypes

• Pre-shapingoftheboneblockdecreasesORtime

Pre-Trimmed Benefits

• Naturalcalcaneusboneblockallowsformultiplefixationtypes

• Largerpre-trimmedboneblockprovidesflexibilityforthesurgeontoshapethebonetobestfitthepatient

• Excellentoptionforbothprimaryandrevisionapplications

Conventional Benefits

• Naturalcalcaneusboneblockallowsformultiplefixationoptions

• Providesthelargestboneblockpossibleforuseinvariousligamentreconstructionprocedures(e.g.primary,revision,PCL,etc.)

To order, call RTI directly: 800.624.7238.

11621 Research Circle

Alachua,FL32615

TollFree:877.343.6832

Fax:386.418.0342

www.rtibiologics.com

©2010 RTI Biologics, Inc. 6247 R0 12-15-10

Ligament Tool Kit Table of Contents

1. Products a. Allograft Tissue Package Insert b. The “Ligamentization” Process in Human Anterior Cruciate Ligament Reconstruction with

Autogenous Patellar and Hamstring Tendons: A Biochemical Study, Marumo et al. c. Allograft Compared with Autograft Infection Rates in Primary Anterior Cruciate Ligament

Reconstruction, Greenberg et al. d. A Systematic Review of Anterior Cruciate Ligament Reconstruction with Autograft Compared

with Allograft, Carey et al.

A. BTB

i. BTB Overview

B. BTB Select

ii. BTB Select Overview iii. Bone Block Comparison Card iv. BTB Select Technique Guide

C. Achilles

v. Achilles Overview vi. Achilles Allograft Use in Anterior Cruciate Ligament Reconstruction, Indelicato

D. Non-Bone Tendons

vii. Non-Bone Tendon Overview viii. Tendon Comparison Overview ix. The Clinical Use of a Four-Stranded Peroneus Longus Allograft in Anterior Cruciate

Ligament Reconstruction, Milia x. Anatomic Double-Bundle Anterior Cruciate Ligament Allograft Reconstruction, Tejwani xi. Analysis of the Biomechanical Properties of Peroneus Longus Tendons Sterilized with

BioCleanse, Pedroso & Zhukauskas 2. Allograft Processing

a. FAQ’s and Handling Objections - Processing b. Clostridium Infections Associated with Musculoskeletal-Tissue Allografts, Kainer et al. c. Allograft Update: The Current Status of Tissue Regulation, Procurement, Processing, and

Sterilization, McAllister, et al. d. Nonirradiated Versus Irradiated Achilles Autograft: In Vivo Failure Comparison, Rappe et al. e. Effects of a Novel Sterilization Process on Soft Tissue Mechanical Properties for Anterior

Cruciate Ligament Allografts, Schimizzi et al. f. Mechanical Properties of Patellar Tendon Allografts Subjected to Chemical Sterilization, Jones,

et al.

g. Anterior Cruciate Ligament Reconstruction with BPTB Autograft, Irradiated Versus Non-Irradiated Allograft: A Prospective Randomized Clinical Study, Sun, et al.

A. BioCleanse®

i. BioCleanse® Elevator Statement ii. Proven Campaign Flyer iii. Proven Campaign: Myth vs. Fact iv. Sports Medicine Patient Brochure v. Allograft Quality Assurance Overview vi. BioCleanse Tissue Sterilization Process Fact Sheet vii. Evaluation of the Sterilization Potential of the BioCleanse Tissue Sterilization Process,

Roberts, et al. viii. Dye Perfusion Into Cadaveric Human Bone as an Indication of Sterilant Penetration,

Roberts et al. ix. Method to Determine Germicidal Inactivation in Allograft Processing, Mills, et al. x. Mechanical Testing of BioCleanse Soft Tissue Allografts, Carr et al.

3. Age a. National Death and Donor Statistics b. Effect of Age on the Mechanical Properties of Human Anterior Tibialis Tendons Sterilized

Through the BioCleanse Process, Pedroso & Myrick

4. Specifications

a. Ligament Reconstruction: Product Label Measurements b. FAQ’s & Handling Objections – Specs c. Avoiding Allograft Length Mismatch during Anterior Cruciate Ligament Reconstruction, Brown et

al. d. “Hybrid” Single-Bundle Anterior Cruciate Ligament Reconstruction: Quadrupled Hamstring

Autograft Combined With Tibialis Anterior Allograft, Tejwani

5. Fees

a. FAQ’s & Handling Objections – Fees b. 2011 RTI List Fees c. AlloSource catalogue d. BioMet Fees e. LifeLink Fees f. LifeNet Fees g. MTF Fees

ALLogrAftprocEssINg

http://ajs.sagepub.com

MedicineAmerican Journal of Sports

DOI: 10.1177/0363546507302926 2007; 35; 1653 originally published online May 21, 2007; Am. J. Sports Med.

Matthew Rappé, MaryBeth Horodyski, Keith Meister and Peter A. Indelicato Nonirradiated Versus Irradiated Achilles Allograft: In Vivo Failure Comparison

http://ajs.sagepub.com/cgi/content/abstract/35/10/1653 The online version of this article can be found at:

Published by:

http://www.sagepublications.com

On behalf of:

American Orthopaedic Society for Sports Medicine

can be found at:American Journal of Sports MedicineAdditional services and information for

http://ajs.sagepub.com/cgi/alerts Email Alerts:

http://ajs.sagepub.com/subscriptions Subscriptions:

http://www.sagepub.com/journalsReprints.navReprints:

http://www.sagepub.com/journalsPermissions.navPermissions:

http://ajs.sagepub.com/cgi/content/abstract/35/10/1653#BIBLSAGE Journals Online and HighWire Press platforms):

(this article cites 36 articles hosted on the Citations

© 2007 American Orthopaedic Society for Sports Medicine. All rights reserved. Not for commercial use or unauthorized distribution. at UNIV OF FLORIDA Smathers Libraries on September 27, 2007 http://ajs.sagepub.comDownloaded from

Ligament Tool Kit Table of Contents

1. Products a. Allograft Tissue Package Insert b. The “Ligamentization” Process in Human Anterior Cruciate Ligament Reconstruction with

Autogenous Patellar and Hamstring Tendons: A Biochemical Study, Marumo et al. c. Allograft Compared with Autograft Infection Rates in Primary Anterior Cruciate Ligament

Reconstruction, Greenberg et al. d. A Systematic Review of Anterior Cruciate Ligament Reconstruction with Autograft Compared

with Allograft, Carey et al.

A. BTB

i. BTB Overview

B. BTB Select

ii. BTB Select Overview iii. Bone Block Comparison Card iv. BTB Select Technique Guide

C. Achilles

v. Achilles Overview vi. Achilles Allograft Use in Anterior Cruciate Ligament Reconstruction, Indelicato

D. Non-Bone Tendons

vii. Non-Bone Tendon Overview viii. Tendon Comparison Overview ix. The Clinical Use of a Four-Stranded Peroneus Longus Allograft in Anterior Cruciate

Ligament Reconstruction, Milia x. Anatomic Double-Bundle Anterior Cruciate Ligament Allograft Reconstruction, Tejwani xi. Analysis of the Biomechanical Properties of Peroneus Longus Tendons Sterilized with

BioCleanse, Pedroso & Zhukauskas 2. Allograft Processing

a. FAQ’s and Handling Objections - Processing b. Clostridium Infections Associated with Musculoskeletal-Tissue Allografts, Kainer et al. c. Allograft Update: The Current Status of Tissue Regulation, Procurement, Processing, and

Sterilization, McAllister, et al. d. Nonirradiated Versus Irradiated Achilles Autograft: In Vivo Failure Comparison, Rappe et al. e. Effects of a Novel Sterilization Process on Soft Tissue Mechanical Properties for Anterior

Cruciate Ligament Allografts, Schimizzi et al. f. Mechanical Properties of Patellar Tendon Allografts Subjected to Chemical Sterilization, Jones,

et al.

g. Anterior Cruciate Ligament Reconstruction with BPTB Autograft, Irradiated Versus Non-Irradiated Allograft: A Prospective Randomized Clinical Study, Sun, et al.

A. BioCleanse®

i. BioCleanse® Elevator Statement ii. Proven Campaign Flyer iii. Proven Campaign: Myth vs. Fact iv. Sports Medicine Patient Brochure v. Allograft Quality Assurance Overview vi. BioCleanse Tissue Sterilization Process Fact Sheet vii. Evaluation of the Sterilization Potential of the BioCleanse Tissue Sterilization Process,

Roberts, et al. viii. Dye Perfusion Into Cadaveric Human Bone as an Indication of Sterilant Penetration,

Roberts et al. ix. Method to Determine Germicidal Inactivation in Allograft Processing, Mills, et al. x. Mechanical Testing of BioCleanse Soft Tissue Allografts, Carr et al.

3. Age a. National Death and Donor Statistics b. Effect of Age on the Mechanical Properties of Human Anterior Tibialis Tendons Sterilized

Through the BioCleanse Process, Pedroso & Myrick

4. Specifications

a. Ligament Reconstruction: Product Label Measurements b. FAQ’s & Handling Objections – Specs c. Avoiding Allograft Length Mismatch during Anterior Cruciate Ligament Reconstruction, Brown et

al. d. “Hybrid” Single-Bundle Anterior Cruciate Ligament Reconstruction: Quadrupled Hamstring

Autograft Combined With Tibialis Anterior Allograft, Tejwani

5. Fees

a. FAQ’s & Handling Objections – Fees b. 2011 RTI List Fees c. AlloSource catalogue d. BioMet Fees e. LifeLink Fees f. LifeNet Fees g. MTF Fees

BIocLEANsE

ALLogrAft procEssINg

Competitor

Comparison

Placeholder

Competitor

Comparison

Placeholder

Ligament Tool Kit Table of Contents

1. Products a. Allograft Tissue Package Insert b. The “Ligamentization” Process in Human Anterior Cruciate Ligament Reconstruction with

Autogenous Patellar and Hamstring Tendons: A Biochemical Study, Marumo et al. c. Allograft Compared with Autograft Infection Rates in Primary Anterior Cruciate Ligament

Reconstruction, Greenberg et al. d. A Systematic Review of Anterior Cruciate Ligament Reconstruction with Autograft Compared

with Allograft, Carey et al.

A. BTB

i. BTB Overview

B. BTB Select

ii. BTB Select Overview iii. Bone Block Comparison Card iv. BTB Select Technique Guide

C. Achilles

v. Achilles Overview vi. Achilles Allograft Use in Anterior Cruciate Ligament Reconstruction, Indelicato

D. Non-Bone Tendons

vii. Non-Bone Tendon Overview viii. Tendon Comparison Overview ix. The Clinical Use of a Four-Stranded Peroneus Longus Allograft in Anterior Cruciate

Ligament Reconstruction, Milia x. Anatomic Double-Bundle Anterior Cruciate Ligament Allograft Reconstruction, Tejwani xi. Analysis of the Biomechanical Properties of Peroneus Longus Tendons Sterilized with

BioCleanse, Pedroso & Zhukauskas 2. Allograft Processing

a. FAQ’s and Handling Objections - Processing b. Clostridium Infections Associated with Musculoskeletal-Tissue Allografts, Kainer et al. c. Allograft Update: The Current Status of Tissue Regulation, Procurement, Processing, and

Sterilization, McAllister, et al. d. Nonirradiated Versus Irradiated Achilles Autograft: In Vivo Failure Comparison, Rappe et al. e. Effects of a Novel Sterilization Process on Soft Tissue Mechanical Properties for Anterior

Cruciate Ligament Allografts, Schimizzi et al. f. Mechanical Properties of Patellar Tendon Allografts Subjected to Chemical Sterilization, Jones,

et al.

g. Anterior Cruciate Ligament Reconstruction with BPTB Autograft, Irradiated Versus Non-Irradiated Allograft: A Prospective Randomized Clinical Study, Sun, et al.

A. BioCleanse®

i. BioCleanse® Elevator Statement ii. Proven Campaign Flyer iii. Proven Campaign: Myth vs. Fact iv. Sports Medicine Patient Brochure v. Allograft Quality Assurance Overview vi. BioCleanse Tissue Sterilization Process Fact Sheet vii. Evaluation of the Sterilization Potential of the BioCleanse Tissue Sterilization Process,

Roberts, et al. viii. Dye Perfusion Into Cadaveric Human Bone as an Indication of Sterilant Penetration,

Roberts et al. ix. Method to Determine Germicidal Inactivation in Allograft Processing, Mills, et al. x. Mechanical Testing of BioCleanse Soft Tissue Allografts, Carr et al.

3. Age a. National Death and Donor Statistics b. Effect of Age on the Mechanical Properties of Human Anterior Tibialis Tendons Sterilized

Through the BioCleanse Process, Pedroso & Myrick

4. Specifications

a. Ligament Reconstruction: Product Label Measurements b. FAQ’s & Handling Objections – Specs c. Avoiding Allograft Length Mismatch during Anterior Cruciate Ligament Reconstruction, Brown et

al. d. “Hybrid” Single-Bundle Anterior Cruciate Ligament Reconstruction: Quadrupled Hamstring

Autograft Combined With Tibialis Anterior Allograft, Tejwani

5. Fees

a. FAQ’s & Handling Objections – Fees b. 2011 RTI List Fees c. AlloSource catalogue d. BioMet Fees e. LifeLink Fees f. LifeNet Fees g. MTF Fees

AgE

The Statistics

2008 United States Death Statistics

2008 United States Donor Estimates

This data was culled from three major sources:

1. U.S. Census Annual Estimates of the Resident Population for the United States, Regions, States, and Puerto Rico: April 1, 2000 to July 1, 2008

2. NATIONAL VITAL STATISTICS REPORTS; U.S. Decennial Life Tables for 1999–2001, United States Life Tables

3. http://www.organtransplants.org/understanding/tissue/ - used for total tissue donors per year statistic

Applying the Statistics to Allograft

Tissue bank xyz distributes 400 grafts per month. If you apply the death stat % then you can assume the

following:

< 40 yr = 64 (16%)

40 – 55 yr = 144 (36%)

55 – 65 yr = 192 (48%)

If you assume failures due solely to age and you assume the surgeon perception that grafts over 40 are inferior

and will fail, then 85% of any tissue banks’ grafts would fail.

THIS IS NOT HAPPENING; THIS IS NOT THE ACCEPTED FAILURE RATE FOR ALLOGRAFT.

The commonly accepted failure rate of allograft is 3-5%.

Ligament Tool Kit Table of Contents

1. Products a. Allograft Tissue Package Insert b. The “Ligamentization” Process in Human Anterior Cruciate Ligament Reconstruction with

Autogenous Patellar and Hamstring Tendons: A Biochemical Study, Marumo et al. c. Allograft Compared with Autograft Infection Rates in Primary Anterior Cruciate Ligament

Reconstruction, Greenberg et al. d. A Systematic Review of Anterior Cruciate Ligament Reconstruction with Autograft Compared

with Allograft, Carey et al.

A. BTB

i. BTB Overview

B. BTB Select

ii. BTB Select Overview iii. Bone Block Comparison Card iv. BTB Select Technique Guide

C. Achilles

v. Achilles Overview vi. Achilles Allograft Use in Anterior Cruciate Ligament Reconstruction, Indelicato

D. Non-Bone Tendons

vii. Non-Bone Tendon Overview viii. Tendon Comparison Overview ix. The Clinical Use of a Four-Stranded Peroneus Longus Allograft in Anterior Cruciate

Ligament Reconstruction, Milia x. Anatomic Double-Bundle Anterior Cruciate Ligament Allograft Reconstruction, Tejwani xi. Analysis of the Biomechanical Properties of Peroneus Longus Tendons Sterilized with

BioCleanse, Pedroso & Zhukauskas 2. Allograft Processing

a. FAQ’s and Handling Objections - Processing b. Clostridium Infections Associated with Musculoskeletal-Tissue Allografts, Kainer et al. c. Allograft Update: The Current Status of Tissue Regulation, Procurement, Processing, and

Sterilization, McAllister, et al. d. Nonirradiated Versus Irradiated Achilles Autograft: In Vivo Failure Comparison, Rappe et al. e. Effects of a Novel Sterilization Process on Soft Tissue Mechanical Properties for Anterior

Cruciate Ligament Allografts, Schimizzi et al. f. Mechanical Properties of Patellar Tendon Allografts Subjected to Chemical Sterilization, Jones,

et al.

g. Anterior Cruciate Ligament Reconstruction with BPTB Autograft, Irradiated Versus Non-Irradiated Allograft: A Prospective Randomized Clinical Study, Sun, et al.

A. BioCleanse®

i. BioCleanse® Elevator Statement ii. Proven Campaign Flyer iii. Proven Campaign: Myth vs. Fact iv. Sports Medicine Patient Brochure v. Allograft Quality Assurance Overview vi. BioCleanse Tissue Sterilization Process Fact Sheet vii. Evaluation of the Sterilization Potential of the BioCleanse Tissue Sterilization Process,

Roberts, et al. viii. Dye Perfusion Into Cadaveric Human Bone as an Indication of Sterilant Penetration,

Roberts et al. ix. Method to Determine Germicidal Inactivation in Allograft Processing, Mills, et al. x. Mechanical Testing of BioCleanse Soft Tissue Allografts, Carr et al.

3. Age a. National Death and Donor Statistics b. Effect of Age on the Mechanical Properties of Human Anterior Tibialis Tendons Sterilized

Through the BioCleanse Process, Pedroso & Myrick

4. Specifications

a. Ligament Reconstruction: Product Label Measurements b. FAQ’s & Handling Objections – Specs c. Avoiding Allograft Length Mismatch during Anterior Cruciate Ligament Reconstruction, Brown et

al. d. “Hybrid” Single-Bundle Anterior Cruciate Ligament Reconstruction: Quadrupled Hamstring

Autograft Combined With Tibialis Anterior Allograft, Tejwani

5. Fees

a. FAQ’s & Handling Objections – Fees b. 2011 RTI List Fees c. AlloSource catalogue d. BioMet Fees e. LifeLink Fees f. LifeNet Fees g. MTF Fees

spEcIfIcAtIoNs

Ligament Reconstruction: Product Label Measurements

BTB SelectA. Width of tendon at insertionsB. Length of tendon between bone blocksC. Total graft length not including tailD. Length of calcaneus bone blockE. Circumference of assemblyF. Length of tailG. Width of calcaneus bone blockH. Height of calcaneus bone block

BTB Pre-Shaped and HemiA. Width of tendon at insertionsB. Length of tendon between bone blocks*C. Total length of graftD. Width of tibia bone block at insertionE. Width of patellar bone block at insertionF. Height of tibia bone block including tendonG. Length of tibia bone blockH. Height of patellar bone block including tendonI. Length of patellar bone block

Achilles Pre-Trimmed/ConventionalA. Total length of graftB. Tendon widthC. Calcaneus bone block lengthD. Calcaneus bone block widthE. Calcaneus bone block height

A

A

EH

DF

C

B

I

G

PATELLAR

GH

A

C

F

D

B BONE

BLOCK

E

D

A

B

C

ED

A

B

C

E

Achilles Pre-ShapedA. Total length of graftB. Tendon width C. Calcaneus bone block lengthD. Calcaneus bone block diameterE. Circumference (pull through) up to flare

*Shortest measurement (medial or lateral)

Not for distribution.

A

B

C

Semitendinosus C. LengthD. Width*E. Pull-through Circumference (folded diameter)*

C

E

D

Gracilis A. LengthB. Width*

A

B

Tibialis/Peroneus A. LengthB. Width*C. Pull-through Circumference (folded diameter)*

11621 Research Circle

Alachua, FL 32615

Toll Free: 877.343.6832

Fax: 386.418.0342

www.rtibiologics.com

©2010 RTI Biologics, Inc. 12-08-10

To order, call RTI directly: 800.624.7238.

*Measured at widest point

The pull-through circumference (folded diameter) is determined by pulling the folded tendon through the appropriate hole in the sizing block.

The pull-through circumference (folded diameter) is determined by pulling the folded tendon through the appropriate hole in the sizing block.

Not for distribution.

Ligament Tool Kit Table of Contents

1. Products a. Allograft Tissue Package Insert b. The “Ligamentization” Process in Human Anterior Cruciate Ligament Reconstruction with

Autogenous Patellar and Hamstring Tendons: A Biochemical Study, Marumo et al. c. Allograft Compared with Autograft Infection Rates in Primary Anterior Cruciate Ligament

Reconstruction, Greenberg et al. d. A Systematic Review of Anterior Cruciate Ligament Reconstruction with Autograft Compared

with Allograft, Carey et al.

A. BTB

i. BTB Overview

B. BTB Select

ii. BTB Select Overview iii. Bone Block Comparison Card iv. BTB Select Technique Guide

C. Achilles

v. Achilles Overview vi. Achilles Allograft Use in Anterior Cruciate Ligament Reconstruction, Indelicato

D. Non-Bone Tendons

vii. Non-Bone Tendon Overview viii. Tendon Comparison Overview ix. The Clinical Use of a Four-Stranded Peroneus Longus Allograft in Anterior Cruciate

Ligament Reconstruction, Milia x. Anatomic Double-Bundle Anterior Cruciate Ligament Allograft Reconstruction, Tejwani xi. Analysis of the Biomechanical Properties of Peroneus Longus Tendons Sterilized with

BioCleanse, Pedroso & Zhukauskas 2. Allograft Processing

a. FAQ’s and Handling Objections - Processing b. Clostridium Infections Associated with Musculoskeletal-Tissue Allografts, Kainer et al. c. Allograft Update: The Current Status of Tissue Regulation, Procurement, Processing, and

Sterilization, McAllister, et al. d. Nonirradiated Versus Irradiated Achilles Autograft: In Vivo Failure Comparison, Rappe et al. e. Effects of a Novel Sterilization Process on Soft Tissue Mechanical Properties for Anterior

Cruciate Ligament Allografts, Schimizzi et al. f. Mechanical Properties of Patellar Tendon Allografts Subjected to Chemical Sterilization, Jones,

et al.

g. Anterior Cruciate Ligament Reconstruction with BPTB Autograft, Irradiated Versus Non-Irradiated Allograft: A Prospective Randomized Clinical Study, Sun, et al.

A. BioCleanse®

i. BioCleanse® Elevator Statement ii. Proven Campaign Flyer iii. Proven Campaign: Myth vs. Fact iv. Sports Medicine Patient Brochure v. Allograft Quality Assurance Overview vi. BioCleanse Tissue Sterilization Process Fact Sheet vii. Evaluation of the Sterilization Potential of the BioCleanse Tissue Sterilization Process,

Roberts, et al. viii. Dye Perfusion Into Cadaveric Human Bone as an Indication of Sterilant Penetration,

Roberts et al. ix. Method to Determine Germicidal Inactivation in Allograft Processing, Mills, et al. x. Mechanical Testing of BioCleanse Soft Tissue Allografts, Carr et al.

3. Age a. National Death and Donor Statistics b. Effect of Age on the Mechanical Properties of Human Anterior Tibialis Tendons Sterilized

Through the BioCleanse Process, Pedroso & Myrick

4. Specifications

a. Ligament Reconstruction: Product Label Measurements b. FAQ’s & Handling Objections – Specs c. Avoiding Allograft Length Mismatch during Anterior Cruciate Ligament Reconstruction, Brown et

al. d. “Hybrid” Single-Bundle Anterior Cruciate Ligament Reconstruction: Quadrupled Hamstring

Autograft Combined With Tibialis Anterior Allograft, Tejwani

5. Fees

a. FAQ’s & Handling Objections – Fees b. 2011 RTI List Fees c. AlloSource catalogue d. BioMet Fees e. LifeLink Fees f. LifeNet Fees g. MTF Fees

fEEs

FAQ’s & Handling Objections – Fees

Why is RTI tissue at a premium fee?

1) Sell the science BioCleanse® sterilization process

o BioCleanse® is a validated low temperature chemical sterilization process.

o It uses a combination of mechanical and chemical processes (oscillating positive and negative

pressure in the presence of the chemical agents).

o BioCleanse removes blood and lipids, and inactivates or removes potential contaminants,

leaving the tissue biocompatible.

o Bone grafts are terminally sterilized by a validated method to achieve a Sterility Assurance Level

of 10-6. Sports medicine tendons are sterilized without irradiation.

Quality Processing

Exceptional recovery and processing of grafts providing consistent high quality allografts.

RTI Innovations

RTI invests money into research to create innovation in the allograft space like BioCleanse®,

Tutoplast, Cancelle SP, and assembled technology.

2) Is RTI willing to discount graft fees?

Understand the facility’s target. Is it price? Is it volume? Is it graft type? Find out the facility usage data

before committing to a discount.

RTI is willing to discount graft fees through the Flex Fee Program. Please work with your RSM on this.

Bundle tissue so that you are maximizing the facilities potential to order multiple graft types at a lower

average fee.

3) I am satisfied with my current supplier; why should I change to RTI Biologics?

Ask probing questions, such as:

“If you could change one thing about your current supplier what would it be?”

(Here you are trying to find a value point for that facility)

“What target overall biologics spend goals are you looking to achieve this year?”

(Here you are trying to start the bundling conversation.)

“Considering the variability of human tissue availability, can we be your second tissue source?”

(Second source agreements often become primary agreements; be ready when their tissue need

arises.)

4) My hospital has a contract with another tissue bank…how can I bring in RTI tissue?

Human tissue contracts are not 100% source agreements and are specific to the tissue bank. Ask to be

a second source and define the specific differences between tissue processing.

The BioCleanse® sterilization process is unique and therefore can lie outside of a contract.

Understand the specific tissue types in the contract and offer to either bundle all biologics as a

primary source or offer to second source for all biologics.