Paving the Way for a New Generation of Biomaterials

CMFlex is the first FDA-cleared fully synthetic 3D-printed regenerative bone graft designed to address a wide range of bony defects in oral and maxillofacial surgical applications. CMFlex is comprised of hydroxyapatite particles and a biodegradable poly(lactide-co-glycolide) (PLG) polymer. By combining these materials through a proprietary process, Dimension Inx created a unique bone graft material that is hydrophilic and highly porous in both macro and microstructure.

CMFlex Implantation in a Multi-Centimeter Porcine Ramus Defect

Study Objective: The objective of this study was to evaluate the performance of CMFlex bone grafts in a large irregular multi-centimeter mandibular defect and its ability to recover the bony contour of the jaw.​

Conclusion: At eight weeks, CMFlex treated defect demonstrated near-complete filling of new bone throughout the defect and recovery of the jaw contour in contrast to the non-treated control.

Read more here.

Hyperelastic Bone: the cutting-edge technology behind CMFlex

Dimension Inx proprietary process combines hydroxyapatite and biodegradable polymer to create a distinctive microstructural surface and innate material porosity for cell adhesion, tissue interaction, and new hard tissue formation. Hyperelastic Bone can be formed into 3D structures, such as CMFlex. To learn more about Hyperelastic Bone and its properties please refer to the articles below.

  • Researchers developed a new synthetic biomaterial called hyperelastic “bone” (HB) to address limitations in current osteoregenerative materials. HB exhibited excellent properties, including rapid 3D-printing, elastic mechanics, high absorbency, and support for cell viability and bone growth. In animal studes, BH showed biocompatibility, tissue integration, and promoted new bone formation without additional factors. These findings highlight the potential of HB as a versatile biomaterial for bone regeneration.

    Reference: Jakus, AE, et al. "Hyperelastic “bone”: A highly versatile, growth factor-free, osteoregenerative, scalable, and surgically friendly biomaterial." Science Translational Medicine, vol 8, no. 358ra127, 2016. doi:10.1126/scitranslmed.aaf7704.

    Read the paper: https://pubmed.ncbi.nlm.nih.gov/27683552/

  • Researchers developed a method to enhance the survival of engineered bone tissue by promoting vascularization. They pre-cultured human smooth muscle cells (hSMCs) on bone scaffolds and seeded human umbilical vein endothelial cells (HUVECs), generating microvascular networks. The addition of hSMCs improved lumen formation and gene expression. Using a perfusion bioreactor further enhanced cellular density and lumen formation. This study advances vascularized bone grafts for tissue engineering.

    Reference: Liu, Xi, et al. "Vascularization of Natural and Synthetic Bone Scaffolds". Sage Publications, 2018. doi:10.1177/0963689718782452.

    Read the paper: https://pubmed.ncbi.nlm.nih.gov/30008231/

  • This study evaluates the effectiveness of a three-dimensionally printed synthetic scaffold called Hyperelastic Bone for bone regeneration in craniofacial reconstruction. The ideal bone substitute should be both osteoconductive and osteoinductive, and the Hyperelastic Bone scaffold meets these criteria with its bioactivity and porosity. In an experiment using rat models with calvarial defects, Hyperelastic Bone showed significant new bone formation compared to a control group treated with Fluffy-poly(lactic-co-glycolic acid) or left untreated. Histological analysis confirmed the integration of new bone around the scaffold. These findings suggest that Hyperelastic Bone grafts have promising potential for clinical use in craniofacial reconstruction.

    Reference: Huang, Yu-Hui, et al. “Three-Dimensionally Printed Hyperelastic Bone Scaffolds Accelerate Bone Regeneration in Critical-Size Calvarial Bone Defects.” Plastic and Reconstructive Surgery, vol. 143, no. 5, 2019, pp. 1397–1407, doi:10.1097/prs.0000000000005530.

    Read the paper: https://pubmed.ncbi.nlm.nih.gov/31033821/