SINTX Technologies, Inc. (www.sintx.com) (NASDAQ:SINT) (“SINTX” or the “Company”), an original equipment manufacturer of advanced ceramics, announced today 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.
“Our successful completion of Phase I aims has shown the feasibility and reliability of 3DP SN-PEEK spinal implants. These 3DP implants met minimum load thresholds in accordance with established mechanical testing standards, demonstrated basic biocompatibility, and resisted bacterial adhesion. These findings established the foundation for this Phase II Small Business Innovation Research (SBIR) award,” said Dr. Ryan Bock, SINTX Vice President of Research and Development and Principal Investigator for the project. “In Phase II, SINTX and external collaborators will conduct formal design validation activities; test static and dynamic mechanical properties of implants 3DP according to the revised design; carry out formal biocompatibility assessments; and assess in vivo antimicrobial activity, biocompatibility, and osseointegration for a 3DP SN-PEEK cervical implant against appropriate controls.”
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.
“In the Phase I effort, Dr. Steven Kurtz of Drexel University and Dr. Noreen Hickok of Thomas Jefferson University were the lead university investigators while Dr. Thomas Schaer of Penn Vet provided valued consultative support for study and implant design. These scientists provided significant contributions to the proposal, and we are grateful for their continued support,” said Dr. Sonny Bal, President, and CEO. “Dr. Schaer will be the lead investigator at Penn Vet while Drs. Kurtz and Hickok will assume advisory roles on the project during execution of Phase II activities. Since the NIH grant will fund the acquisition of needed benchtop data and the first ever in vivo performance data for SN-PEEK devices, the award represents a critical milestone in expanding the antibacterial and osseointegrative properties of silicon nitride into composite structures. From a commercial standpoint, this NIH-funded project is an important step in our strategy to introduce a new generation of highly differentiated implants into the spine market.”
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.
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