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SINTX Technologies was awarded a Phase II grant of $1,972,826 by the National Institutes of Health (NIH) to develop a 3D-printed composite silicon nitride/polyetheretherketone (SN-PEEK) spinal implant. This represents the fourth NIH grant awarded to SINTX since the Phase I award for this project was received in 2021.
SINTX aims to combine the familiarity and benefits of PEEK with the antibacterial and osteoconductive characteristics of silicon nitride. These composite implants will be manufactured with modern 3D printing technologies.
SINTX will collaborate with the University of Pennsylvania School of Veterinary Medicine (Penn Vet) over the next 24 months to execute this project. The NIH grant will support resourcing and acquisition of materials as well as testing and trials at SINTX and Penn Vet. Upon successful execution of the Phase II grant application goals, SINTX will have the majority of the benchtop and large animal in vivo data needed to seek FDA regulatory clearance using the 510(k) pathway. Additionally, successful demonstration of infection prevention in vivo will be a critical step toward enabling an antimicrobial device claim. These preliminary animal data will be used to seek future funding from NIH or other Federal agencies to further validate antimicrobial properties of devices made from SN-PEEK.
Source: SINTX Technologies, Inc.
