Material and science
What the catalogue and Ventas Bio’s data on file report about AmGraft®. Each statement is labelled by type of evidence.
IFU Catalogue v5.0 Company description Preclinical (animal) In vitro
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Composition Catalogue v5.0
The catalogue lists three calcium phosphate phases: hydroxyapatite (HA), octacalcium phosphate (OCP) and tricalcium phosphate (TCP). The IFU describes the material as a dentin matrix made from human teeth.
Structure Catalogue v5.0
| Property | Catalogue value |
|---|---|
| Pore size | 0.9–2.0 µm |
| Volumetric porosity | 12–32% |
| Surface roughness (Ra) | 0.67–0.88 µm |
| Collagen | Partial collagen matrix exposure |
| Chip size | 0.5–1.0 mm |
The catalogue does not state the measurement methods.
Processing: HaptoTech ATRS Company description
The catalogue states that AmGraft® is “engineered with HaptoTech ATRS” (Advanced Tissue Regeneration System). Ventas Bio describes three stages: decontamination, microstructuring and optimisation. The catalogue describes the technology as patent-pending. Ventas Bio’s quality management system is described as aligning with ISO 13485:2016.
Preclinical data Preclinical (animal)
Animal study, data on file at Ventas Bio. Not peer-reviewed. Rabbit femoral implantation, 4 weeks, compared with allogenic corticocancellous bone.
| Measure (4 weeks) | AmGraft® | Allogenic bone |
|---|---|---|
| Bone-implant contact | 30.93% | 16.27% |
| Bone-only sites | 53.44% | 16.76% |
| New bone formation score | 3.3 | 1.5 |
| Host reaction score | 5.5 | 6.9 |
Animal results do not predict clinical outcomes in patients.
In-vitro data In vitro
Cell culture, data on file at Ventas Bio. PCR in SAOS-2 cells and human dermal fibroblasts reported upregulation of SMAD1 (p<0.01), SMAD5 (p<0.0001), ITGA2 and ITGB1.
In-vitro gene expression does not demonstrate a clinical effect.
What is not available
We have found no peer-reviewed clinical publication on AmGraft®. Published studies on tooth-derived grafts mostly use the patient’s own extracted teeth. Those results do not transfer to AmGraft®. See Tooth-derived bone grafts, explained.