1 combioss. 2...to create the optimal bone void filler: porous inside, stable outside. Learning from nature... The Bionic Solution humerus head, µ-CT,

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Presentation transcript:

1 combioss

2...to create the optimal bone void filler: porous inside, stable outside. Learning from nature... The Bionic Solution humerus head, µ-CT, © Scanco AG combioss

3 Morphology Spherical granules available in the range of 315 < ø < 1600µm Macroporous granules Porosity > 50% Interconnected micro-porosity Pore size ≈ 5µm

4 Morphology Comparison combioss Competitor: dense structure

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

6 Chemical Composition Chemical pure  -TCP  -TCP with calcium pyrophosphate (K)  -TCP containing HA (B) Transmission [%] Wavelength [cm -1 ] combioss Competitor C Competitor K Competitor B

7 Solubility COMBIOSSCKBF Solubility tests: pH 3, T = 37°C, 3 hours combioss is completely soluble! (ISO ) Solubility [%]

8 Abrasion [%] AbrasionBulk densityPorosity C competitorcombioss Porosity [%] Bulk density [gcm -3 ] C competitorcombiossC competitorcombioss Physical Properties

9 Pure-phase -tricalciumphosphate (>99%  -TCP) Interconnected porosity Porosity > 50% Osteoconductive 100% synthetic Spherical granules  315µm µm Simultaneous resorption to bone growth Complete resorption proven Properties

10 Analytics Identity Phase purity by XRD and IR Porosity Bulk Density Mechanical stability of granules, Abrasion Granules geometry and color Complete solubility by ISO Heavy metals All production processes are validated. The following parameters are analyzed for each production lot:

11 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): 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

12 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

13 Advantages l Less material to fill defect l Taking up blood l Minimal generation of small particles Porous inside, stable outside Complete resorption Pure  -phase >99% l Purity > ASTM

14 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

15 Available Sizes Ref-Nr.ContentGranule Size CBO x 0.5 ml µm CBO x 1.0 ml µm

16 Case Report Initial X-raysDetachment

17 Case Report Detachment

18 Case Report Impacted canine toothExtraction of impacted canine tooth

19 Case Report Post-extraction socket Cavity filling with Combioss

20 Case Report Cavity filling with Combioss and CGF Cavity filling with CGF membrane

21 Case Report Cavity filling with CGF membrane Stitched wound, covered with serum

22 Case Report Stitched wound, covered with serum3 days after surgery

23 Case Report Quality of the tissues after 3 daysX-rays after 45 days