PUROS 2009

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February 2006 Part# 6120 Rev. Date 01/06

Confidence in your hands™Dental

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Confidence in your hands™

Confidential – Internal Use Only!

Who is Zimmer Dental?

Part # 7140, rev. 12/06

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Zimmer Dental Regenerative Products

Biomend® / Biomend® Extend

Puros® Corticocancellous

Block

Puros® Dermis

CollaTM Products

Puros® Pericardium

Puros® Cortical Particles

Puros® Cancellous Particles

Availability: Puros ® – US, Canada, Latin America BioMend ® – Global (with some extensions)Colla™ – Everywhere but EU and AustraliaSocket Repair Membrane – US only (available on Jan. 31, 2007)

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Regenerative Products in Europe:

BioMend® Collagen Barrier Membranes:

CollaTape®CollaCoteTM CollaPlug®

BioMend®

BioMend® ExtendTM

Colla® Absorbable Collagen Wound Dressings*:

Zimmer® Socket Repair Membrane*:

*pending CE mark registration

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BioMend Specifications

15mm X 20mm

20mm X 30mm

30mm X 40mm

• Packaged in a single blister pack, within a Tyvek envelope

• Two year shelf life

• No special storage requirements

Membrane size selection:

• 15 x 20mm, majority of defects• 20 x 30mm, distal or interproximal defects• 30 x 40mm, multiple defects on one patient

Competitive advantage: AlloDerm® requires refrigeration(Life Cell Corporation Branchburg, New Jersey)

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BioMend® Features and Benefits

• Tear-resistant and pliable• Easy-to-handle even when hydrated• May be cut without fraying or fragmenting• Strong enough to be sutured• Adaptable to root surfaces

Excellent Handling

• Type I collagen helps stabilize and maintain clot in defect space

• Enhances healing and improved regeneration

Wound Stabilization

Competitive advantage: ePTFE (GORE) membranes are not hemostatic

Competitive advantage: Bio-Gide® and Alloderm® must be placed “right side up”


Knees Confidence in your hands™Dental Confidence in your hands™


Absorbable Collagen Wound Dressings

CollaPlug®

CollaTape®

CollaCoteTM

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Colla Wound Dressings Features and Benefits

• Controls bleeding and stabilizes blood clots• Covers and protects the wound bed

• Provides matrix for tissue ingrowth• Accelerates healing process

• Fully absorbs within 14 days

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CollaTape®

• Part Number 0100• 2.5 cm x 7.5 cm• 10 units per package

• Minor oral wounds:• Closure of osseous grafted

sites• Sinus - Repair of

Schneiderian Membranes (mucous membrane lining nasal chambers)

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CollaCoteTM

• Part Number 0101• 2 cm x 4 cm• 10 per package

• Minor oral wounds:• Palatal donor sites• Mucosal flaps• Intraosseous defects• Around implants

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Case: Palatal donor site treated with CollaCoteTM

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CollaPlug®

• Part Number 0102• 1 cm x 2 cm• 10 per package

• Extraction sites• Biopsy sites• Oral wounds




Zimmer® Socket Repair Membrane

Confidential

CONFIDENTIAL - Internal Use Only. Do Not Distribute.

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Case 1 Dennis Tarnow, DDS

New York, NY

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Case 1 – Dennis Tarnow, DDS

Periapical Radiograph

Dennis Tarnow, DDS

Dennis Tarnow, DDS

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Membrane Placed in Socket

Dennis Tarnow, DDS

Dennis Tarnow, DDS

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Puros Particulate Delivered into Socket

Dennis Tarnow, DDS

Dennis Tarnow, DDS

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Membrane Sutured in Place

Dennis Tarnow, DDS

Dennis Tarnow, DDS

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2 Weeks Post-Op

Dennis Tarnow, DDS

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2 Months Post-Op

Dennis Tarnow, DDS

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Final Esthetic Result

Dennis Tarnow, DDS

Richard Smith, DDS

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50,000 sq. ft. administration building

65,000 sq. ft. processing facility

• Tutogen Medical, Inc. founded 1971

• Regeneration Technologies, Inc. founded in

1998

• Merger in February 2008 to form RTI

Biologics, Inc.

• Processing locations: Alachua, FL Neunkirchen, Germany

RTI Biologics Overview

For internal use only- Do not distribute

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FAMILIA PUROS

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The TUTOPLAST® Process

Tutoplast es el un proceso patentado de esterilización y preservación que consiste principalmente en una serie de baños químicos que aseguran la eficiencia y seguridad de los tejidos sometidos a este.

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Delipidización

Bañando los tejidos en

acetona y agitados con

ultrasonido.

La acetona es evaporada.

Elimina grasa para impedir su

interferencia con la

cicatrización.

Inactiva virus

Remueve bacteria

Proceso TUTOPLAST®

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Tratamiento Osmótica

Único del Tutoplast

Serie de baños ( altas y bajas

concentraciones de solución salina

y agua destilada)

Expone el material intracelular

permitiendo la eliminación de el

material bacteriano.

Mata bacterias

Destruye y elimina células

Elimina la mayoría de la

antigenicidad

Reduce el volumen viral

Proceso TUTOPLAST®

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Tratamiento Oxidativo

Baños con bajas

concentraciones de

peroxido de hidrogeno

Reacciona con las

proteínas

Remueve la antigenicidad

restante

Inactiva los virus

expuestos en el

tratamiento osmótica.

Proceso TUTOPLAST®

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Deshidratación con solvente

Baño con agua destilada.

7 baños de acetona.

Elimina el agua del tejido (lo que

permite almacenar el tejido por 5

años)

Inactiva los priones virales

remanentes.

Remueve bacteria

Conserva la estructura del tejido y

su firmeza

Proceso TUTOPLAST®

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Asegura la completa esterilidad y 5 años de almacenamiento

Se hace con el producto empacado

NO afecta las propiedades biomecánicas del tejido

Inactiva virus

Un máximo 2.5 mrad

Dosis limitadas de irradiación Gamma

Proceso TUTOPLAST®

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Cortical Bone

Dense, rigid bone tissue, cylindrical in shape and hard enough that surgeons must use a saw or drill to cut through it.

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Cortical Bone

Bone Structure

Forms the entire outside of the bone

Is very denseIs very strong

Highly resistant to compression and bending

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Cancellous Bone

La capa mas interna , también conocida como hueso trabecular o medular

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When is Puros fully matured ?What`s left after 6 months ?

(Puros after internal sinus lift, 8 months post op)

Following the recommended re-entry periods and the instructions for use,the following histological findings can be expected:• vital cancellous bone with lamellar structure • fat marrow with areas of collagen connective tissue• visible cement lines of layered bone remodeling and apposition of new bone• conclusive integration of a small amount of transplant residues

Traces of residual Puros are solidly integrated into newly formed, hard bleeding bone,complete turnover is depending on subsequent natural remodeling at the grafted site with respect to stress trajectories and general cellular activity.

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Aplicaciones del hueso

CORTICAL.

• RECONSTRUCCION DEL HUESO ALVEOLAR

• SOBRE IMPLANTES

• DEFECTOS PERIODONTALES

• ELEVACION DEL SENO MAXILLAR•

• EXTRACCION DE 3 MOLARES

ESPONJOSO.

• EXTRACCIONES ANTES DE IMPLANTES

• DEFECTOS PERIODONTALES

• ELEVACION DEL SENO MAXILLAR




Puros®

J-Block!

Confidential

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A = 18 mmB = 10, 15C = 8 mm

5 mm

A

C

2 mm B

Puros Block (J-Block): Uses/Indications

• Taken from Iliac crest – both cortical and cancellous• The J-Block Allograft is specifically designed for surgical ridge augmentation

of mandible or maxilla in patients where bone volume has been reduced due to atrophy in both vertical and lateral dimensions.

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Knees Confidence in your hands™Dental

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Puros® Pericardium Clinicals:Case 2- Horizontal and Vertical

Ridge Augmentation with Puros J-Block

By Paul PetrungaroDDS, MS, FICD, FACD, DICOI

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Pre-Operative View

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Pre-Operative Defect

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Block Sizing

Puros Block Allograft

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Block Re-hydration – Saline First; PRP coating, if desired, afterward

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Puros Block Fixation

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Rehydration of Puros Particulate & Pericardium Regenerative Complex

Puros Particulate Puros Pericardium

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Pericardium Membrane Placed

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Tension Free Closure

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6 Week Post Operative View

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3 Month Post Operative Panorex

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3 Month Post Operative Clinical View

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3 Month Re-Entry

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Site Preparation Implant Placement

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Re-Shaping RidgeOne Stage Implant Protocol

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Closure

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6 Months Post J-Block-Loading

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Definición del hueso Puros• Procesado con Tutoplast

• Mineralizado

• Esponjoso, cortical, bloque iliaco

• Alogenetico

• Osteoconductivo

• Conserva el colágeno con toda su pureza

• Estéril

1%

14%0.3%

50%

2%

33%

Cells

Type I Collagen

NoncollagenousproteinsHA

Other Minerals

WaterSTERILE R

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Manejo y consistencia




Puros® PericardiumResorbable Allograft Membrane

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Pricing

Product Description Price Puros Pericardium, 15X20mm $135 Puros Pericardium, 20X30mm $199 Puros Pericardium, 30X40mm $249

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Definición del Pericardio Puros

• Alogenetico

• Colágeno permanece intacto

• Procesado con Tutoplast

• Pericardio humano

• 5 años de almacenamiento

• Rígido con fibras multidireccionales.

• Se reabsorve entre 4 a 6 meses

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Pericardium

• Tejido conectivo denso que rodea el músculo del corazón

• El pericardium esta compuesto de colágeno tipo I.

• Funciones:

Proteger el corazón. Adhiere el corazón a las paredes

adyacentes. Previene el corazón de llenarse de

sangre. Limita los movimientos del corazón.

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Definición del Pericardio Puros

• Alogenetico

• Colágeno permanece intacto

• Procesado con Tutoplast

• Pericardio humano

• 5 años de almacenamiento

• Rígido con fibras multidireccionales.

• Se reabsorve entre 4 a 6 meses

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Que hace al Pericardio Puros superior?

• Fácil de hidratar.

• Alta adaptabilidad a los tejidos

• Fácil de manipular

• Predecible absorción.(4 a 6 meses)

• Acepta todo tipo de dispositivos de fijación

• Resistente

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Aplicaciones de el Pericardium

• Sobre injertos de bloques

• Sobre injertos de reconstrucción alveolar

• Sobre extracciones

• Sobre defectos periodontales

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Puros® Pericardium Clinicals:Case 1- Ridge Preservation

By Paul PetrungaroDDS, MS, FICD, FACD, DICOI

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Pre-Operative View

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Regenerative Barrier

Puros PericardiumPuros Pericardium

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Treatment of the Osseous Defects

Puros Particulate

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PRP Enhanced Graft Complex and Membrane

Pericardium Membrane

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3 Month Re-entry and Placement of Implants

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3 Month Re-Entry3 Month Re-Entry

Pre-Op DefectPre-Op Defect

CoreCore

3 Month Re-Entry3 Month Re-Entry

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Puros® Dermis Allograft Tissue Matrix

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Dermis

• Skin is the largest organ in the body. It contains 3 layers: Epidermis Dermis Subcutaneous

• Functions: Protection Provides strength Thermoregulation Supports vascular and nerve network Sensation Delivers nutrients

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Caracteristicas

• De facil uso Segundos para hidratarla (no

necesita de antibioticos) No necesita de segunda cirugia Excelente respuesta de los tejidos Esteril

• Fuerte , con fibras multidireccionales• No requiere de refrigeracion• 5 años se puede guardar • Biocompatible• Compuesta de Collageno tipo 1• Se reabsorve entre 4 a 6 meses

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Hydration using PRP

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Puros Dermis in Place and Sutured

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Product Positioning - Dermis

Providing an easy-to-use, sterile solution, Puros® Dermis is a natural alternative to autogenous soft tissue grafts.

It can be used for both horizontal and vertical soft tissue augmentation, increasing volume and leading to a highly cosmetic clinical result.

Puros Dermis offers superb soft tissue response and maturation, ideal for aesthetic case requirements.

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Congelado-Desecado Vs Tutoplast

Congelado-Desecado (liofilizado)

(Largas vesículas debido a los cristales de hielo áreas densas no uniformes)

Tutoplast processed(Apariencia uniforme)

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Mineralizado Vs Desmineralizado

• Mineralizado

― Mejor matriz para el hueso remodelar― Soporte ― Estructura― Arquitectura

• Desmineralizado

― Se remodela mas rápido que el hueso del paciente, así perdiendo volumen

― Osteoinduccion??????

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Proj. T15b

• RTI Overview

• DBM Basics

• What Is It?

• How It’s Made

• Puros DBM Putty Product Description

• Competitive DBM Products

RTI & Zimmer


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What Is It?

• 100% processed allograftActive DBM*

Carrier DBM

Water

• Open bore dispensers

*DBM induced bone formation when implanted in an athymic rat assay. Findings from an animal model are not necessarily predictive of human clinical results.


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+ +Carrier DBM

=


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Zimmer® Sinus Lift Balloon

Zimmer Dental has signed an Exclusive Distribution Agreement with Osseous Technologies of America (OTA) for a product line of Sinus Lift Balloons

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©2009 Zimmer Dental Inc. All rights reserved. 1289, Rev. 8/09.

Zimmer® Sinus Lift Balloon

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FAQsWhat is the Sinus Lift Balloon?Zimmer® Sinus Lift Balloon is a unique device to assist clinicians in performing atraumatic sinus membrane elevation.

What is the price of a Sinus Lift Balloon?$129 each (no discounting)

What are the part numbers?14002 – Straight14003 – Angled14004 – Micro-Mini

Availability?US – October 2009Canada – 2Q10EU/ROW – 1Q10 (APR countries vary based on product registry)

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How to use a Sinus Lift Balloon*

Clinical photos ©2009 Dr. Ronald Cardoso. All rights reserved. Individual results may vary.

Step 5 Step 6 Step 7

S5) Insert deflated balloon into osteotomyS6) Slowly and evenly inflate balloon with saline to lift sinus membraneS7) Deflate balloon and remove from osteotomy, inspect sinus membrane. Site is now ready to receive graft material

*Refer to the IFU for further information and detailed steps.

S1) Determine which balloon you need for the indicationS2) Inflate the balloon with air, pump multiple times to expand balloonS3) Create an osteotomy S4) Fill the syringe with saline

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LITERATURE

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Documents

PUROS 2009