The broader impact/commercial potential of this I-Corps project is the development of a new class of spinal interbody fusion cages with multi-functional features. Specifically, the medical device is designed to promote new bone formation in the intervertebral space and also inhibit infections. Both of these implant capabilities are critical as they will result in the expedited recovery of patients undergoing spinal fusion surgery. The proposed technology also may reduce the total treatment cost for patients as the cage holds the potential to eliminate the use of additional proteins and implant coatings as well as reduce the use of antibiotics. The spinal fusion device market is projected to increase substantially in the future, and the proposed technology may fill a key gap by introducing a product that may enhance the recovery rate in patients with degenerative spinal problems at a lower cost than current therapeutics.

This I-Corps project is based on the development of a medical device that uses a multi-functional, polymer-bioceramic composite to create a spinal interbody fusion cage. Previous fundamental research indicated that the composite formulation may address the limitations related to the currently used polyether etherketone (PEEK) polymer cages. Specifically, the proposed cage composition may bind to neighboring bone effectively and also promote new bone formation promptly as shown using in vitro and in vivo models. Based on these results, the proposed implant may challenge the usage of traditional PEEK cages and establish the advantages of utilizing PEEK-bioceramic composite cages in spinal fusion. In addition, the inclusion of the bioceramic, magnesium phosphate, as the bioactive component may challenge the usage of its well-known counterpart, calcium phosphate. The proposed implant also may support the development of polymer-magnesium phosphate composite formulations not only for interbody cages but for other orthopedic implants and implant accessories. If successful, the proposed technology may confirm the feasibility and generate the knowledge required to use the Fused Filament Fabrication technique to design composite interbody cages as an alternative to other manufacturing methods. Biomechanical testing of the implants may provide the necessary knowledge required to design market-ready interbody cages.

This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.

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Cleveland State University
United States
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