Tetranite is a gamechanger for clinicians striving to improve outcomes across the range of human and animal bone repair applications. Currently there is no FDA approved biomaterial with the adhesive, osteo-conductive, and bioresorbable qualities that Tetranite possesses—all qualities which have been proven in existing pre-clinical animal studies. Tetranite is poised to become the first commercially available synthetic adhesive bone graft.
Tetranite is an injectable, self-setting material that is highly cohesive enabling it to be placed into a wet surgical environment without being washed away during its application. The material hardens within minutes and, during its curing process, forms adhesive bonds to both bone and metallic surfaces. As a result, the material is capable of withstanding separation forces when used to adhere bone fragments together or to fixate metallic implants to bone when there is insufficient existing bone contact. Given its structural properties, RevBio is developing applications both to augment the fixation strength of existing metal implant devices and also applications for its stand-alone use with possible load-bearing applications.
Tetranite uniquely combines two naturally occurring compounds–Tetracalcium Phosphate (TTCP) and the amino acid O-Phospho-L-Serine (OPLS) within an aqueous medium. Upon curing in situ, Tetranite forms a multiphasic solid that is predominantly amorphous; however, several crystalline phases in lower proportion include (a) calcium-phosphoserine-monohydrate, (b) hydroxyapatite, (c) unreacted tetracalcium phosphate, and (d) unreacted α-tricalcium phosphate. Once on the market, Tetranite will become the first synthetic bone adhesive. As a synthetic product, Tetranite does not rely on large molecules and therefore can be produced in large quantities at a low cost.
Tetranite supports the body’s natural healing and bone regeneration process by providing a structure into which bone can infiltrate. Given the highly amorphous structure, which is dominated by ionic and coordination bonds, loss of ions from the cured substance is mediated by gradual dissolution as interstitial fluid contacts and penetrates the surface of Tetranite, leaving channels for bony ingrowth. New bone deposition (a reparative process naturally programmed into the connective tissue cells) is supported by neovascularization that develops in the Tetranite porosities and zones where the amorphous phase of the material has dissolved away. This is a continuous process that lasts for months until most of the Tetranite material is progressively resorbed and replaced by new bone during the healing process. The final removal of the residual crystallites of the most stable phase, hydroxyapatite, is carried out by multinucleated giant cells, the normal agents involved in the turnover of mineralized tissue.
Tetranite has a unique Mechanism of Action. The components in Tetranite react within minutes to yield a uniquely adhesive composite system. After hardening, Tetranite is bioengineered to withstand tensile and shear bond stresses as high as 3 MPa, similar to the strength of human cancellous bone. The Tetranite scaffold is osteoconductive and bioactive, leading to the eventual replacement of Tetranite with new bone. Over time, load bearing responsibility is transferred to the new tissue such that mechanical integrity is maintained.