Alpha-Bioalphabioendpoint.azureedge.net/media/2686/biomaterials-catalog.pdfAlpha-Bio's GRAFT Cancellous Block is composed of pure cancellous bone. The formation of the block supports

Alpha-Bio Tec, a world leader in advanced implantology solutions, is proud to present its growing biomaterials product line: Alpha-Bio's GRAFT, which has taken a leading position in the global dental biomaterials market over the past few years.

Today, Alpha-Bio Tec offers a complete portfolio of Xenograft, Allograft and Synthetic bone substitutes and resorbable membranes. The company's development strategy and vast market experience in implant dentistry combine to create a comprehensive product line that suits the requirements of implantologists. Alpha-Bio's GRAFT offers the best combination of quality & value with efficient, easy-to-use products that meet a wide variety of dental procedures from the simplest to the most demanding ones.

The combination of these benefits allows dentists to focus on the surgical procedure and ensure patients have a natural healing process, long-lasting clinical effectiveness and excellent aesthetic results.

A GrowinG SucceSS3

Granules Size Small (0.5-1mm)

Volume 0.5cc 1cc 2cc 5cc

Ref. No. 3225 3236 3207 3206

54

Alpha-Bio's GRAFT removes all organic components, resulting in a protein free Hydroxyapatite ceramic mineral similar to the human bone and allowing for excellent integration and bone formation. The unique proprietary processing of this product assures excellent long term volume preservation as well as exceptional patient blood resorption ability, resulting in superior handling qualities.

Large (1-2mm)

2cc 5cc

3232 3237

Xenograft AlphA-Bio'S GrAFT nATurAl Bovine Bone

Main Characteristics: • Similar to human bone • Hydrophilic surface with large internal surface area• Interconnective high porosity with optimal pore size distribution &

quantity supports top line vascularisation

Benefits:• High level of osteoconductivity• Convenient usage with superb liquid uptake• High quality & volume of new formed bone

Key Advantages

Product of choice for long term volume preservation. Supports immediate loading when applicable

Group Xenograft

Source Bovine

Components Biologic Hydroxyapatite

Resorption Resistible to resorption

ProcessOsteoconduction, referred as non resorbable

AdditionalRadiopacity allows easy x-ray identification & diagnosis

SEM X 50Prominent similarity to

human bone

SEM X 30Numerous inter connected pores

with rounded surface area to minimize risk of fenestration

SEM X 500Intact surface area both inside and outside the macropores

Excellent porosity and surface structure*

* Provided by Tel Aviv University - Wolfson Applied Materials Research Center. Images are decreased by 40%.

Alpha-Bio's GRAFT Synthetic, Resorbable Bone is an innovative, fully synthetic biphasic bone substitute with exceptional controlled resorption properties and outstanding handling characteristics. The homogenous composition of 60% hydroxyapatite (HA) and 40% Beta-Tri Calcium Phosphate (β-TCP) results in two mineral phases of activity: supporting the formation of new vital bone, while maintaining volume and mechanical stability. Alpha-Bio's GRAFT Synthetic, Resorbable Bone features high osteoconductivity and high macroporosity, supporting osteogenic cell growth and regeneration of vital bone.

Granules Size Small (0.5-1mm)

Volume 0.5cc 1cc

Ref. No. 3201 3202

Large (0.8mm-1.5mm)

0.5cc 2cc

3203 3204

Synthetic AlphA-Bio'S GrAFT SynTheTic, reSorBABle Bone

Main Characteristics: • Homogeneous phase distribution• Available bioactive phosphate and calcium ions

Benefits:• Controlled resorption suits a wide diversity of procedures• Supports new bone mineralization process

Key Advantage

Product of choice for those seeking best results with a fully synthetic product

Group Synthetic (Alloplastic)

Source Fully synthetic (biphasic)

ComponentsBiphasic 60% hydroxyapatite and 40% β-Tricalcium Phosphate

Resorption Dual phase resorption process

ProcessOsteoconduction, partially resorbable

AdditionalRadiopacity allows easy x-ray identification & diagnosis

SEM X 500Rough surface area

Rough hidrophilic extensive surface area*


SEM X 5000Hydrophilic surface area

SEM X 2000Large surface area

SEM X 85Extensive cancellous surface

~500µm~2mm ~1mm ~100µm

SEM X 50High porosity granules

~100µm ~10µm~20µm~1mm

Bone SUBStitUteS

Granules Size Small (0.2-0.85mm)

Volume 0.5cc

Units 1 syringe

Ref. No. 3272

Granules Size Small (0.2-0.85mm)

Volume 0.5cc 1cc

Units 1 syringe 2 syringe

Ref. No. 3249 3250

Large (0.5-1mm)

2cc 5cc

1 vial 1 vial

3254 3258

6

Alpha-Bio's GRAFT Corticocancellous Granules combines freeze dried cortical and cancellous bone. The combination of cortical and cancellous bone provides the variety of characteristics required to enable high quality new vital bone formation. In addition to excellent integration, this product offers ideal regeneration as it allows unification of the resorption and regeneration curves. Further, it has high osteoconductive abilities and provides a scaffold for new bone growth, allowing for a first-rate fitting for the widest possible range of procedures among all allograft products currently available on the market. The product is provided in a vial or an included syringe, which enables prompt rehydration with saline or the patient's blood.

allograftS corTicocAncellouS GrAnuleS* (FDBA – Freeze DrieD Bone AlloGrAFT)

Main Characteristics: • Natural human bone reach in collagen• Cortical parts provide structural support and space-maintaining capability • Cancellous component offers a porous architecture for new blood vessle formation (angiogenesis)

Benefits:• Natural integration with newly forming bone allows good drilling sense while placing implants• Excellent bone remodeling due to adequate combination of cortical and cancellous bone supporting

osteoconduction and revascularization

Key Advantages

Product of choice in diversity of procedure fit & regeneration efficiencyAllows dentist & patients quickre-entry time for implant placement

Group Allograft

Source Human donation

ComponentsCorticocancellous, cortical & cancellous bland

Resorption Resorbable

Process Osteoconduction

Natural human bone structure**

* Available in selected countries.** Provided by Tel Aviv University - Wolfson Applied Materials Research Center. Images are decreased by 40%.

7

Bone SUBStitUteS

Alpha-Bio's GRAFT Demineralized Cortical Granules Syringe is comprised of freeze dried cortical bone, which has undergone a demineralization process. This process exposes the growth factors that are naturally available within the bone, supporting both osteoconduction and osteoinduction mechanisms. The osteoinductive ability was proven to accelerate the formation of natural bone. The included syringe enables prompt rehydration with saline or the patient's blood.

Main Characteristics: • Natural human bone – rich in collagen and essential

biological components for new bone formation• Both osteoconductive & osteoinductive

Benefits:• Natural prompt integration with newly forming bone• Facilitates attachment of osteogenic precursor cells

Key Advantages

Product of choice for minor defects not requiring Guided Bone Regeneration, Allows minimal re-entry time (when applicable)

Group Allograft


Components Cortical bone


Process Osteoconduction & osteoinduction

Intact Collagen structures, natural surface area and well distributed pores

DeminerAlizeD corTicAl GrAnuleS* (DFDBA – DeminerAlizeD Freeze DrieD Bone AlloGrAFT)

* Available in selected countries.** Provided by Tel Aviv University - Wolfson Applied Materials Research Center. Images are decreased by 40%.*** Provided by Tel Aviv University - Center for Nanoscience and Nanotechnology - Wolfson Applied Materials Research Center. Images are decreased by 40%.

SEM X 500Intact osteoconductive surface area

SEM X 50Natural human bone structure

SEM X 2000Rough surface area with macro,

micro and nano porosity

SEM X 100**General granule

SEM X 1,500**Natural collagen structure

ESEM X 10,000***Micro & nano porosity

ESEM X 300***Multi porosity surface area

~1mm ~100µm ~20µm ~20µm~400µm ~10µm~500µm

Syringe

8

Alpha-Bio's GRAFT Cancellous Block is composed of pure cancellous bone. The formation of the block supports cell expansion within the block matrix, while enabling ideal blood vessel formation. This process results in the creation of new cell aggregation that supports the creation of new bone formation.

allograftS cAncellouS Block 10x10x10*

Main Characteristics: Natural high osteoconductive framework & ability of the cancellous structure offers top line architecture for new blood vessel formation (angiogenesis)

Benefits:• Full vascularization support allows fast remodeling of high quality patient bone• Minimize morbidity and provide an alternative for secondary surgery using

autogenous bone

Key Advantage

Product of choice for horizontal augmentation when usage of particulate form alone is not applicable

Group Allograft


Components Cancellous bone



9

Size 10x10x10mm

Ref. No. 3261

Ideal blood vessels matrix with intact collagen structures

Alpha-Bio's GRAFT Corticocancellous Block is a double layered, one piece block consisting of cortical and cancellous natural layers. The dual layer block enables the ideal use of bone qualities for both fixation and healing processes.

allograftS corTicocAncellouS Block 6x12x20*

Main Characteristics: • One piece of original corticocalncellous bone • Natural high osteoconductive framework & ability of the cancellous structure offers

adequate architecture for vasqularization

Benefits:• Cortical layer allows friendly fixation• Full vascularization support allows fast remodeling of patient bone

Key Advantage

Product of choice for horizontal augmentation when usage of particulate form alone is not applicable

Group Allograft


Components Corticocancellous human bone



Size 6x12x20mm

Ref. No. 3260



Natural surface area with maximal porosity**

SEM X 200**Pores split area shows intact bone

& collagen structure

SEM X 20**Edge shows high porosity & original cancallous macro & micro structure

SEM X 200**Natural collagen structure

~200µm~2mm

SEM X 20**General cancellous area view

~2mm ~200µm

Bone SUBStitUteS

reSorBaBle MeM

BraneS


Size 20x20mm

Content 12 separately packed units

Ref. No. 3205

Size 15x20mm 20X30mm 30X40mm

Ref. No. 3246 3242 3212

10

Alpha-Bio's GRAFT Collagen Membrane provides an effective barrier function for epitel cells as well as an excellent matrix for new blood vessel growth. Due to its unique production process, the superior properties of the native pericardium are preserved, maintaining the characteristics of this natural tissue. The membrane provides rapid rehydration and easy manipulation during use in both wet and dry conditions and is naturally resorbed.

AlphA-Bio'S GrAFT collAGen memBrAne

Main Characteristics: • Efficient barrier function with Epithelium cells occlusivity • Fully resorbed supporting structure for vascularization • Easy to shape, tear proof, non-chemical crossed linked collagen

Benefits:• Finest support for both Guided Bone Regeneration (GBR) & Guided Tissue

Regeneration (GTR)• Eliminates the need for a second procedure and supports new high

quality bone and tissue formation due to excellent vascularization abilities• Exceptional adaptability to surface contours. • Returns to flat position when re-dried to allow re-fit to surgical site

Key Advantage

Pericardium membrane provides leading barrier function capabilities

Group Resorbable organic membrane

Source Native collagen (pericarduim)

Resorption Fully resorbed

Process Barrier function

Smooth epitel barrier layer with multilayer collagen matrix for new blood vesicles growth*

11

Alpha-Bio's GRAFT Collagen Fleece is a pH-neutral, wet-stable, haemostatic native collagen sponge. The potent haemostatic effect of the collagen is induced by the adhesion of platelets to the collagen fibrils. As a result, platelets aggregate and release coagulation factors. This initiates the coagulation cascade resulting in hemostasis. The neutral PH level which is unique for this product prevents soft tissue irritation. The product's flexible compressible structure allows a convenient manipulation by the dentist and adequate fit for wide range of procedures.

AlphA-Bio'S GrAFT collAGen Fleece

Main Characteristics: • Potent haemostatic effect, facilitates adhesion of platelets to the collagen fibrils • Fully resorbed supporting non dense structure

Benefits:• Excellent ability to stabilize fitting surgical sites by fast haemostasis• Easily manipulated to fit all indicated spaces• Supports prompt natural healing

Key Advantage

Prompt resorption time & neutral PH level supports natural healing

Group Biological collagen

Source Porcine


Process Enables soft tissue healing

Easily manipulated structure with phenomenal blood uptake and wound healing support

* Provided by Tel Aviv University - Wolfson Applied Materials Research Center. Images are decreased by 40%.** Provided by Tel Aviv University - Center for Nanoscience and Nanotechnology - Wolfson Applied Materials Research Center. Images are decreased by 40%.

SEM X 500Edge showing dense epitel barrier

layer and inner structure

~100µm

SEM X 1000Internal structure showing adequate

blood vessel supporting matrix

~50µmESEM X 100**

General view of 3D structureSEM X 500*

Collagen fleece fibers

~100µm~1mm

Product Group Bone Substitutes Resorbable Membranes

Source Xenograft Synthetic Allograft Biological Collagen Synthetic

Product Image

Product NameNatural Bovine Bone

Synthetic, Resorbable

Bone

Corticocancellous Granules

Demineralized Granules

Cancellous Block

Corticocancellous Block

Collagen Membrane

Collagen Fleece

Biocryl Membrane

Sinus Floor Elevation

Socket / Ridge Preservation

Horizontal Augmentation

Vertical Augmentation

Periodontal Defects

Covering Palatinal Gingival Donor Sites

EstimatedRe-entry time(by months)1

8-9 6-8 6-8 6-8 8 8

Estimated Main Integration(by months)1

<9 <4 <6 2-3 6-8 6-8 3 1 2

Size 10x10mm 10X20mm 20X30mm

Ref. No. 3151 3152 3153

12

Alpha-Bio's GRAFT Biocryl Membrane is made from a synthetic absorbable copolymer of glycolide and lactide, a closely woven material which consists of non-dyed suturing fibers. Alpha-Bio's GRAFT Biocryl Membrane is primarily a separating structure for therapeutic oral surgery.

AlphA-Bio'S GrAFT Biocryl memBrAne*

Main Characteristics: • Fully resorbed closely woven matrix fiber structure• Minimizes inflammation and tissue irritation

Benefits:• Excellent ability to physically stabilize surgical sites and act as a short term partial barrier• Supports quick healing

Key Advantage

Strong fully and promptly resorbed matrix structure providing physical support for complex grafting sites

Group Synthetic

Source Synthetic copolymer

Components Copolymer of glycolide and lactide


SEM X 50**Biocryl membrane matrix view

SEM X 200**Biocryl closely woven fibers

13

cUt & SaVeAlphA-Bio'S GrAFT SAmple DATA & proceDureS TABle1


1 Data in this document is provided as general example only. It is based on a combination of manufacturers IFU's, professional literature and manufacturer//supplier written materials. Appropriate product selection and usage quantity must be determined based on dentist's clinical judgment considering patient systemic conditions, bone type, defect severity, and additional parameters when required. Reported values can vary depending on patient and defect clinical condition.

Wide match Optional match

~1mm ~200µm

14 15

clinical caSe reportScaSe 1 nATurAl Bovine Bone

Bone Substitutes

Source Xenograft Synthetic Allograft

Product Name

Natural Bovine Bone Synthetic, Resorbable Bone Corticocancellous Granules Demineralized Granules

Cancellous Block

Corticocancellous Block

Size Small (0.5-1mm)

Large (1-2mm)

Small (0.5-1mm)

Large (0.8-1.5mm)

Small (0.2-0.85mm)

Large (0.5-1mm)

Small (0.2-0.85mm) 10X10X10mm 6X12X20mm

Volume 0.5cc 1cc 2cc 5cc 2cc 5cc 0.5cc 1cc 0.5cc 2cc 0.5cc 1cc 2cc 5cc 0.5cc 1 1

Units 1 1 1 1 1 1 1 1 1 1 1 syringe

2 syringe

1 vial

1 vial

1 syringe 1 1

Ref. no. 3225 3236 3207 3206 3232 3237 3201 3202 3203 3204 3249 3250 3254 3258 3272 3261 3260

proDucT coDeS AnD reF. no.

Resorbable Membranes

Source Biological Collagen Synthetic

Product Name

Collagen Membrane Collagen Fleece Biocryl Membrane

Size 15X20mm 20X30mm 30X40mm 20X20mm 10X10mm 10X20mm 20X30mm

Units 1 1 1 12 1 1 1

Ref. no. 3246 3242 3212 3205 3151 3152 3153

Dr. Alessandro Bermond Des Ambrois - M.D.Italy

A clinical case of a very extended post-extraction bone defect with a chronic infection. In this case, a GBR intervention was planned, using biomaterial of bovine origin (Alpha-Bio's GRAFT, Israel) together with a CGF technique (Concentrated Growth Factors), which is obtained by a specific blood separator (Medifuge, Silfradent, Italy). It should be noted that the bone defect is comprised of a complete loss of the buccal cortical plate and wide palatal fenestration. After 6 months it became possible to insert an implant into the regenerated site with a small peri-implant regeneration.

Pre-operative x-ray Follow up x-ray after 2 months, following extraction

Healing of soft tissuesafter 8 weeks

Bone defect present withpalatal fenestration

Biomaterial in situ withCGF blend

Suture obtaining primaryclosure of the wound

Bone healing. Follow upx-ray after 4 months

Healing of soft tissuesafter 6 months

Healing after 6 months Preparation of the implant site in regenerated bone

Implant in situ Peri-implant regeneration Healing of the soft tissues 1 month after surgery

Follow up x-ray

1 2 3 4 5

6 7 8 9 10

11 12 13 14

DR. LEIF RoTENBERG - D.D.S, Specializes in oral & Maxillofacial Surgery. Israel

A 57 years old woman, experiencing 22-24 edentulous combined with significant bone lack in both vertical and horizontal dimensions - an applicant for implant based restoration. With the aim of repairing the osseous contour, a block onlay grafting was performed using an allograft corticocancellous block combined with Alpha Bio's GRAFT Natural Bovine Bone. Grafted site was covered by Alpha Bio's GRAFT Collagen Membrane.

16

clinical caSe reportScaSe 3 AlphA Bio'S GrAFT collAGen Fleece

DR. YANIv MAYER – D.M.D, Periodontist. Israel

Sinus floor elevation while handling a tear in the Schneiderian membrane. A 55 years old male patient, normally healthy, required a sinus floor elevation in order to place implants.

The prepared window required for sinus floor elevation, exposing a tear

in the Schneiderian membrane

Collagen Fleece was placed under the Schneiderian membrane in order to support tear closure and separate prepared grafting material disperse

within the sinus

Placement of a natural bovine bone to gain volume in the sinus

Covering grafted area with Alpha-Bio's GRAFT

Collagen Membrane

9 month following grafting procedure, implants were located on right upper quadrant. An adequate

bone formation around the implants following the procedure is shown

1 2 3 4 5

caSe 2 SynTheTic, reSorBABle BoneDR. LuCA SAvIo - B.D.SItaly

A case of immediate post-extraction regeneration with covering of the biomaterial (beta tricalcium phosphate 40% and hydroxyapatite 60%), is described by means of a collagen membrane (Alpha-Bio's GRAFT, Israel) left exposed in the oral environment in accordance with the socket preservation technique described by several authors. This enabled the preservation of bone volume as well as the extraction, with healing of the soft tissues as secondary intention. The histology obtained after 5 months shows an initial bone healing with the presence of lamellar bone at depth and woven bone more superficially. The bone quality found allowed insertion of the fixture, however, having practiced open alveolar regeneration, a further peri-implant reconstruction at a coronal level was necessary, as is often the case when applying this method. These issues were all described by Dutch authors in their systematic review of the literature, which concluded that the best technique is still to wait for the soft tissues to heal, making closed regeneration possible, more protected and consequently more predictable (Ten Heggler, 2011).

Palatal probing ata root fracture

Pre-operative x-ray Immediate post extractive regeneration

Collagen membrane exposed with healing by secondary closure

Follow up x-ray ofpost-extractive regeneration

Surgery re-entry after 5 months following socket preservation

Coring of theregeneration obtained

Histology of the postextractiveregeneration obtained

Implant inserted and additional peri-implant regenerative

1 year post surgery x-ray follow up (fully restored)

1 2 3 4 5

6 7 8 9 10

caSe 4 corTicocAncellouS Block – on lAy GrAFTinG

CT view pre operative procedure (1-3)

1 2

CT view post operative procedure (4.5 months post operation) shows adequate healing and sufficient bone volume supporting implants (4-6)17

3

4 65

18

caSe 5 AlphA Bio'S GrAFT collAGene memBrAneDR. DR. DANIEL RoTHAMEL – M.D, D.M.D, Ph.D, Specializes in oral and Maxillofacial Surgery. Germany

19

clinical caSe reportScaSe 6 corTicocAncellouS GrAnuleS (FDBA)

DR. YANIv MAYER – D.M.D, Periodontist. Israel

A 47 years old woman, usually healthy, shows a broken tooth (No.11) in gingival height with secondary caries and failed root treatment.

Front tooth root (No. 11) remaining with no rehabilitation option

Atraumatic extraction with preservation of the buccal plate and

with no severance of the periost

Socket volume preservation using abundant filling of the socket with

Alpha-Bio's Graft Corticocancellous Granules

Socket opening cover with Alpha-Bio's GRAFT

Collagen Membrane

Surgical site closure using live connective tissue taken

from the palate. Suturing using 5/0 Nylon sutures

1 2 3 4 5

Surgical site post operation view (following 4 month of

healing) shows good volume preservation of the ridge

Surgical site post operation view (following 4 month of healing)

shows good esthetic result

Three dimensional CT simulation shows complete volume preservation

and fine bone recovery

Insertion of Alpha-Bio Tec SPI implant in the exposed osseous

ridge following 4 month of healing. Ridge bone looks vital with no bone substitute residues

Suturing of the surgical site post implant insertion

6 7 8 9 10

Instable bridge situation with abscess formation at tooth 15

after apicectomia

OPG 6 months after tooth extraction shows vertical

deficiency at 15

Clinical situation with scar formation at former abscess

incision site

Mucoperiosteal flap elevation reveals a bone-containing defect at 15 and a

non-containing lateral bone defect at 14 – 12

In progress of implant bed preparation at 12, 14 and 15,

bone chips are collected

Light bone spreading at 12 for lateral widening of the crest

Internal sinus grafting to compensate the vertical

deficiency at 15

After implant installation, lateral bone defects need further

augmentation

Mixture of small granules of Natural Bovine Bone with the

harvested autogenous bone chips

Application of the graft material on the lateral aspect

Application of a long-lasting pericardium membrane (Collagen Membrane) to separate the graft from the soft tissue

Tense-free soft tissue closure is mandatory for undisturbed

soft tissue healing

Postoperative X-ray showing the position of implants and

internal sinus grafting

Stable conditions after 6 month healing period

Perfect integration of the bovine bone in newly formed

bone matrix

1 2 3 4 5

6 7 8 9 10

11 12 13 14 15

Implant uncovering and installation of gingival healing abutments

Prosthetic situation after one year and professional oral hygiene

Radiological situation after one year

16 17 18

We are proud to invite new and existing customers to experience this innovative, high-value, easy-to-use product line.

exactdesign.co.il995-0199 R5/08.13

Alpha-Bio's GRAFT products are CE-marked in accordance with the Council Directive 93/42/EEC and Amendment 2007/47/EC or complies with FDA requirements. Products are available in selected countries.

1 Alpha-Bio's GRAFT Collagen Membrane integration 4 weeks following procedure2 Corticocancellous Block 6x12x203 Cancellous Block 10x10x104 Alpha-Bio's GRAFT Synthetic, Resorbable Bone 6 Months Following Sinus Lift5 Alpha-Bio's GRAFT Natural Bovine Bone Integration 6 Months Following Sinus Lift6 Alpha-Bio's GRAFT Synthetic, Resorbable Bone7 Alpha-Bio's GRAFT Natural Bovine Bone8 Alpha-Bio's GRAFT Natural Bovine Bone

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Documents

Alpha-Bioalphabioendpoint.azureedge.net/media/2686/biomaterials-catalog.pdfAlpha-Bio's GRAFT Cancellous Block is composed of pure cancellous bone. The formation of the block supports