aler medical || reoss
DESCRIPTION
Aler Medical || ReOssTRANSCRIPT
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
••••••
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 • [email protected]
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