SUB-MICRON HA INFUSED SYNTHETIC BIOMATERIAL

ReOss® Powder

Indication

ReOss® Sub-Micron HA Infused Synthetic Biomaterial

ReOss® has a multi-pore three-dimensional architecture thatcreates an environment for new bone growth. The scaffoldalso provides a hospitable adhesive substrate that serves as astrong physical support for the infusion and growth of bonecells. The entire structure is an intricate, highly interconnectedmatrix with enhanced hydrophilic properties. Through a

patented process utilizing barosynthesis, the biomaterial’shighly porous, synthetic polymer foam is permeated withosteoconductive sub-micron sized particles of HA. ReOss’sbone-like foam scaffold, osteoconductivity, and increasedhydrophilic surface provide an environment for thestimulation of bone regeneration.

ReOss® is indicated for use in filling and/or augmenting intraoral/maxillofacial osseous defects; such as infrabony/intrabonyperiodontal osseous defects, furcation defects, alveolar ridge osseous defects, tooth extraction sites and in sinus elevationprocedures.

Sub-Micron HA Particlescan begin to be seen permeating the

PGLA Matrix at 50,000x.

Red highlights are used here

as visual aid.

SEM Image of ReOss®Biocomposite

10,000x Showing Porous Nature

of the PLGA Matrix

SEM Image of ReOss® Biocomposite

300x Showing Internal Structure

of an Individual Granule

HAHA

HAHA

Color codedcontainer caps

for easierproduct recognition

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Reference List

1. Poly (lactide-co-glycolide)/hydroxyapatite composite scaffolds for bone tissue engineering. Kim etal. Biomaterials 27(2006) 1399-1409.

2. A poly (lactide-co-glycolide)/hydroxyapatite composite scaffold with enhanced osteoconductivity.Kim et al. Journal of Biomedical Research Part A Vol 80A Issue 1, pp 206-215.

3. Comparison of Osteogenic Potential Between Apatite-Coated Poly (lactide-co-glycolide)/Hydroxyapatite Particulates and Bio-Oss. Kim et al. Dental Materials Journal 2008; 27(3): 368-375.

4. Peripheral nerve regeneration within an asymmetrically porous PLGA/ Pluronic F127 nerve guideconduit. Oh et al. Biomaterials 29(2008) 1601-1609

5. Sterilization, toxicity, biocompatibility and clinical applications of polylactic acid/polyglycolic acidcopolymers. Athanasiou et al. Biomaterials 17 (1996) 93-102

6. In vitro biocompatibility of bioresorbable polymers: poly(L-lactide) and poly(lactide-co-glycolide).A. Ignatius, L. E. Claes Biomaterials, Volume 17, Issue 8, 1996, Pages 831-839

7. Biodegradation and biocompatibility of PLA and PLGA microspheres. James M. Anderson, Matthew S.Shiva Advanced Drug Delivery Reviews Volume 28, Issue 1, 13 October 1997, Pages 5-24

8. Resorbability of bone substitute biomaterials by human osteoclasts. Schilling et al. Biomaterials,Volume 25, Issue 18, Aug 2004, pp 3963-3972.

9. The biodegradation of hydroxyapatite bone graft substitutes in vivo. Rumpel et al. Folia MorphologyVolume 65, No 1, pp 43-48

10. Biocompatibility of Scaffold Components and Human Bone Fetal Cells. Montjovent et al. EuropeanCells and Material Vol.5. Suppl. 2,2003 p.79

11. Biodegradable and bioactive porous polymer/inorganic composite scaffolds for bone tissueengineering. Rezwan et al. Biomaterials 27(2006) 3413-3431

12. Physico/Chemical characterization, in vitro and in vivo evaluation of ReOss® and Synthograftparticulate grafting materials. Coimbra et al.

Technical Properties

Available Configurations Catalogue No. Volume

ReOss® Bone Growth Initiator is a high purity biocomposite which is synthesized utilizing a special process involving highpressure formation.

Typical Composition

Purity

Porosity

Pore Size

Particle Size

Resorption Time

50% Hydroxyapatite (Ca10(PO4)6(OH)2)50% Poly(lactide-co-glycolide)

<50 ppm Heavy Metals

>70 %

Macropores = 15-300 micronsMicropores < 10 microns

500-1000 microns

From 6 to 12 Months

ReOss® Powder:

ReOss® Putty:

ReOss® Injectable Gel:

RP-1 0.5cc

RP-3 1cc

RP-2 0.5cc

RP-4 1cc

RG-1 0.5cc

RG-2 1cc

SUB-MICRON HA INFUSED SYNTHETIC BIOMATERIAL

Barosynthesized BioComposite

Overview of ReOss®: A Resorbable Bone-like Biocomposite PLGA/HA:Poly (lactic-co-glycolic) acid / Hydroxyapatite

ReOss® is a composite biomaterial comprised of two phases - a PLGA biodegradable polymer and a bioceramic. The polymer

provides a structurally stable, porous and biocompatible5,6,7 three-dimensional matrix to which biological fluids can penetrate,

and cells can adhere.The HA bioceramic, due to its chemical and structural similarity to the mineral phase of native bone, allows

the biocomposite to create a bond with the living host bone.2,11

Sub-Micron-HA Particles

In order to improve the bioactivity of the ceramic phase, ReOss® utilizes Sub-Micron-sized particulate Hydroxyapatite (HA).

This particulate size HA shows improved osteointegration and faster degradation times over larger particulate HA, which

can impede bone growth because of its slow biodegradation.1,2 Sub-Micron-sized HA also has been reported to augment

protein adsorption and cell adhesion, further improving the ability for bone to regenerate.2

Multi-pore Resorbable Structure

The porosity of the polymer matrix of ReOss® also provides an excellent environment to aid in stimulating bone regeneration.

Through a patented process involving high-pressure formation of the polymer matrix, ReOss® is replete with both macro and

micropores. The micropores allow biological fluids and small molecules, which aid in cell growth to perfuse the matrix,

enveloping and sustaining the osteogenic cells that attach to the macropores of the scaffolds. As the cells begin to grow and

develop, both phases of the biocomposite degrade, leaving behind a stable, natural bone matrix.7,8,9

Osteodynamics

Several studies have shown that biodegradable polymer/bioceramic composites can improve bone regeneration as

compared with conventional composites by optimizing controlled resorption, osteogenesis and osteointegration.1,2,11 By

controlling the parameters which determine the characteristics of resorption and osteoinductivity, ReOss® provides a superior

vector for the stimulation of new bone growth.

• 100% Synthetic

• Osteo Adhesive Topography

• Strong 3-D Scaffold

• Osteoconductive

• Enhanced Hydrophilicity

ReOss® is hydrophilic and configured as a multi-pore three-dimensional scaffold engineered to integrate with the

physiochemical state of bone tissue.

GLOBAL HEADQUARTERS6560 West Rogers Circle, Bldg. 24Boca Raton, Florida 33487 USA

Tel: 877-330-0338www.intra-lock.com • info@intra-lock.com

Intra-Lock® and ReOss® are registered trademarks of Intra-Lock® International, Inc.

U.S. & Foreign Patents Pending.

0499 • EC Rep: Intra-Lock System Europa, Srl., I-84100 Salerno • © Copyright 2009, Intra-Lock® System International • S4EN-09-07CE