As advanced manufacturing hardware and software, including 3D-printing related platforms, have continued to rapidly improve, the development of highly biofunctional materials, compatible with these advanced manufacturing platforms, generally has not. Additionally, due to the economics and logistics of healthcare, as well as substantial regulatory requirements, any new technology that is developed and deployed must satisfy additional criteria related to cost, quality, scalability, and overall manufacturability - ideally being relevant for both mass- and point-of-care manufacturing. In this presentation, Dimension Inx’s advanced biomaterial technology platform, 3D-Paints and 3D-Painting, will be discussed, with particular focus given to the highly osteoregenerative 3D-Painted material, Hyperelastic Bone, its development, use, and upcoming translation to clinical use in the form of mass-manufactured, 3D-printed devices.
3D-Painting is a distinct, materials-centric advanced manufacturing technology that permits nearly any material, from biological tissues to ceramics, metals, alloys, and more to be 3D-printed via simple, rapid room-temperature extrusion without the need for support materials, support baths, powder-beds, resin baths, cross-linking, or curing. All 3D-Paints are co-3D-printing compatible with each (multi-material fabrication) and may even mixed or blended prior to or during 3D-printing to create compound 3D-paints. Although many hundreds of 3D-Paints have been developed to date, the highly osteoconductive Hyperelastic Bone (HB) for maxillofacial repair. HB is a 90% calcium phosphate ceramic that, despite its composition, is highly surgically friendly, capable of being easily cut and press fit into defects, as well as, in the case of thin sheets, folded and contoured to complex surface defects. It is highly absorbent and wicking, which assists in the rapid integration and vascularization of the material with surrounding biological tissues.
In this presentation, the 3D-Paint and 3D-Painting approach will be summarized along with a selection of Hyperelastic Bone in vivo implant results, including those from rat and Rhesus macaque calvarial defects, among others. Additionally, quality manufacturing of mass-produced off-the-shelf, 3D-printed HB structures will be discussed, along with experiences and learning from moving the technology from the laboratory to scaled, quality-controlled manufacturing in preparation for clinical maxillofacial repair and reconstructions applications.