SINTX Technologies, Inc. announced it has been awarded a Phase II grant of $1,972,826 by the National Institutes of Health (NIH) to develop a 3D printed (3DP) 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 September of 2021.

Representing approximately 40% of spine implants within the $10 billion global spine market, PEEK-based devices are favored because of their proven clinical efficacy. Through the development of 3DP SN-PEEK spinal implants, 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, cost-effective 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 the 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 towards 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. Research reported in the ?3D Printed Silicon Nitride Porous PEEK Composite Spinal Cages for Anti-Infection?

proposal was supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases of the National Institutes of Health under award number 2R44AR083836-02.