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3D Printed Silicon Nitride Porous PEEK Composite Spinal Cages for Anti-Infection

Award Number: R44AR083836
ORGANIZATION: NATIONAL INSTITUTE OF ARTHRITIS & MUSCULOSKELETAL & SKIN DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/15/2021
PERIOD OF PERFORMANCE END DATE: 08/31/2026

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3D Printed Silicon Nitride Porous PEEK Composite Spinal Cages for Anti-Infection - PROJECT SUMMARY Spinal fusion is the standard treatment for persistent neck and back pain, but the hardware used to stabilize the fusion can harbor or even promote bacteria that lead to persistent, difficult-to-treat infections that are costly and damaging to patient health. Among the available materials for spinal fusion, polyether-ether-ketone (PEEK) cages stand out due to their strength, biocompatibility, and radiolucency, but like other materials, they are susceptible to spinal infections. Silicon nitride (Si3N4) spacers have been used in other spinal applications where their rates of reportable adverse events due to infection are much lower than industry norms, but they are not ideal for stabilizing spinal fusions due to their potential for subsidence and brittle fracture. To address this challenge, SINTX used Phase I SBIR funding to develop and test a 3D-printed Si3N4-PEEK material that incorporates the antimicrobial and osseointegrative properties of Si3N4 with the strength and elasticity of PEEK. In this Phase II SBIR, SINTX proposes to use this material to develop a 3D-printed anti-microbial spinal fusion cage that promotes osseointegration, withstands in vivo loading, and facilitates imaging. The project includes long-term biomechanical performance and in vivo fusion property testing in both normal and contaminated operative scenarios. Successful completion of these activities will position SINTX to prepare a 510(k) premarket notification application for FDA. SINTX anticipates further development and commercialization of a 3D-printed Si3N4-PEEK spinal fusion cage will provide orthopedic surgeons a high-performance fusion device that could greatly reduce the incidence of fusion-associated infections. Aim 1. Minimize potential design and manufacturing hazards by formal design and process risk management analyses in accordance with ISO 14971. Milestone: Completion of the design FMEA and process FMEA per ISO 14971 to minimize risks associated with the novel cervical cages and design freeze. Aim 2. Verify that the finalized 3DP Si3N4-PEEK cervical cage meets the static and fatigue loading requirements of ASTM F2077 and subsidence requirements of ASTM F2267. Milestone: Following the design freeze in Aim 1, demonstrate static and fatigue compression, shear, and torsion strength and subsidence resistance of the finalized 3DP Si3N4-PEEK’s porous cage meets or exceeds the guidelines for cervical cages established by ASTM F2077 and ASTM F2267 and benchmarked for many cage manufacturers in the literature. Aim 3. Determine antimicrobial activity (experimental arm) and in vivo biocompatibility and osteointegration (biocompatibility GLP arm) for a 3DP Si3N4-PEEK cervical cage in a caprine model of cervical spinal fusion. Milestone: Final, packaged, and validated implants will pass requirements in ISO 10993. 3DP Si3N4-PEEK implants will have biocompatibility, bone ingrowth, fusion, and resistance to infection comparable to or better than control 3DP PEEK spinal cages.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $745,427 )
2025	2025	SINTX TECHNOLOGIES, INC.	1885, WEST 2100 SOUTH	SALT LAKE CITY	UT	84119	SALT LAKE	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	3	9/9/2025	NON-COMPETING CONTINUATION	$745,427
														Subtotal = $745,427

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2023	SINTX TECHNOLOGIES, INC.	1885, WEST 2100 SOUTH	SALT LAKE CITY	UT	84119	SALT LAKE	USA	Arthritis, Musculoskeletal and Skin Diseases Research	001	2	9/4/2024	COMPETING CONTINUATION	$0
2024	2023	SINTX TECHNOLOGIES, INC.	1885, WEST 2100 SOUTH	SALT LAKE CITY	UT	84119	SALT LAKE	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	2	11/2/2023	COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $1,227,401 )
2023	2023	SINTX TECHNOLOGIES, INC.	1885, WEST 2100 SOUTH	SALT LAKE CITY	UT	84119	SALT LAKE	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	2	9/22/2023	COMPETING CONTINUATION	$1,227,401
														Subtotal = $1,227,401

Grand Total All Awards = $1,972,828

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3D Printed Silicon Nitride Porous PEEK Composite Spinal Cages for Anti-Infection

Award Number: R44AR083836

ORGANIZATION: NATIONAL INSTITUTE OF ARTHRITIS & MUSCULOSKELETAL & SKIN DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/15/2021

PERIOD OF PERFORMANCE END DATE: 08/31/2026

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