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combioss

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...to create the optimal bone void filler: porous inside, stable outside.

Learning from nature...

The Bionic Solution

humerus head, µ-CT, © Scanco AG

combioss

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Morphology

Spherical granulesavailable in the range of 315 < ø < 1600µm

Macroporous granulesPorosity > 50%

Interconnected micro-porosityPore size ≈ 5µm

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Morphology Comparison

combioss

Competitor: dense structure

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Crystal phase purity

X-ray diffraction- (left) and infrared-spectrum (right) prove -phase purity of > 99%

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100

01000200030004000

Wavelength [cm-1]

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Chemical Composition

Chemical pure -TCP -TCP with calcium pyrophosphate (K)-TCP containing HA (B)

Tra

nsm

issi

on [

%]

Tra

nsm

issi

on [

%]

Wavelength [cm-1] Wavelength [cm-1]

combioss

Competitor CCompetitor K

Competitor B

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Solubility

COMBIOSS C KBF

Solubility tests: pH 3, T = 37°C, 3 hours

combioss is completely soluble! (ISO 109913-14)

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lub

ilit

y [%

]

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Ab

rasi

on

[%

]

Abrasion Bulk densityPorosity

C competitor combioss

Po

rosi

ty

[%]

Bu

lk d

ensi

ty

[gcm

-3]

C competitor combioss C competitor combioss

Physical Properties

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Pure-phase -tricalciumphosphate (>99% -TCP) Interconnected porosity Porosity > 50% Osteoconductive 100% synthetic Spherical granules 315µm - 1600µm Simultaneous resorption

to bone growth Complete resorption proven

Properties

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Analytics

Identity Phase purity by XRD and IR Porosity Bulk Density Mechanical stability of granules, Abrasion Granules geometry and color Complete solubility by ISO 109913-14 Heavy metals

All production processes are validated. The following parameters are analyzed for each production lot:

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Biocompatibility and Bone Formation

Good biocompatibility Good osteoconductivity Granules are osteointegrated Degradation and resorption via

solubility, osteoclastic action and macrophages

Resorption rate depends on implantation site (loads, fluid exchange): 9 - 15 months

Complete resorption proven in scientific study in animal model

Sheep, super critical size hole model of 8mm in femur, after 2 months

Combioss granules

Light blue:

pre existing bone

Dark blue: new bone

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Human Histology

Osteoid (red): bone formation in progress,

Bone Formation within combioss granules

Osteointegration process of RootReplica™ (combioss) after 6 months, human histology of alveolar process

Dark green: new bone

Combioss granules

Light green: undifferentiated tissue invaded by osteoids

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Advantages

Less material to fill defect Taking up blood Minimal generation of small

particles

Porous inside, stable outside

Complete resorption

Pure -phase >99% Purity > ASTM

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Indications

Filling of bone defects after extirpation of cysts Defects in corrective osteotomy Defects after the extraction of a tooth Sinus floor elevation surgery Periodontal and peri-implants defects Defects after harvesting of autogenous bone Augmentation of alveolar bone

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Available Sizes

Ref-Nr. Content Granule Size

CBO-0500-05 5 x 0.5 ml 315 - 500 µm

CBO-0500-10 5 x 1.0 ml 500 - 1000 µm

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Case Report

Initial X-rays Detachment

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Case Report

Detachment Detachment

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Case Report

Impacted canine tooth Extraction of impacted canine tooth

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Case Report

Post-extraction socket Cavity filling with Combioss

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Case Report

Cavity filling with Combioss and CGF Cavity filling with CGF membrane

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Case Report

Cavity filling with CGF membrane Stitched wound, covered with serum

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Case Report

Stitched wound, covered with serum 3 days after surgery

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Case Report

Quality of the tissues after 3 days X-rays after 45 days