| NSF Org: |
TI Translational Impacts |
| Recipient: |
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| Initial Amendment Date: | March 19, 2021 |
| Latest Amendment Date: | May 21, 2021 |
| Award Number: | 2118528 |
| Award Instrument: | Standard Grant |
| Program Manager: |
Ruth Shuman
rshuman@nsf.gov (703)292-2160 TI Translational Impacts TIP Directorate for Technology, Innovation, and Partnerships |
| Start Date: | March 1, 2021 |
| End Date: | August 31, 2022 (Estimated) |
| Total Intended Award Amount: | $50,000.00 |
| Total Awarded Amount to Date: | $50,000.00 |
| Funds Obligated to Date: |
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| History of Investigator: |
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| Recipient Sponsored Research Office: |
2121 EUCLID AVE CLEVELAND OH US 44115-2226 (216)687-3630 |
| Sponsor Congressional District: |
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| Primary Place of Performance: |
2121 Euclid Avenue Cleveland OH US 44115-2214 |
| Primary Place of
Performance Congressional District: |
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| Unique Entity Identifier (UEI): |
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| Parent UEI: |
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| NSF Program(s): | I-Corps |
| Primary Program Source: |
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| Program Reference Code(s): |
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| Program Element Code(s): |
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| Award Agency Code: | 4900 |
| Fund Agency Code: | 4900 |
| Assistance Listing Number(s): | 47.084 |
ABSTRACT
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.
PROJECT OUTCOMES REPORT
Disclaimer
This Project Outcomes Report for the General Public is displayed verbatim as submitted by the Principal Investigator (PI) for this award. Any opinions, findings, and conclusions or recommendations expressed in this Report are those of the PI and do not necessarily reflect the views of the National Science Foundation; NSF has not approved or endorsed its content.
1. Established/formalized relationships with industry/commercialization partners.
2. Established collaboration with an industry mentor/commercialization partner who helped significantly in understanding the business and logistics of spinal fusion cages.
2. Wrote a PFI-TT grant in collaboration with some of the industry partners, commercialization partners and industry mentor, such that the PFI-TT grant will help us develop the functional prototype/minimum viable product (MVP). It will give us the opportunity to validate this MVP in the market and perform product compliance testing.
3. We developed the value proposition of our product as follows. Our unique “knowledge engineered” product, Ultra-PEEK, offers bioactive and antibacterial features in a standalone cage that will allow spine surgeons to reduce rehospitalizations and lower recovery time and system costs by over 50% in fusion procedures. Also, the 3D printed Ultra-PEEK cages will reduce 70% of production cost and time, improving supply chain efficiency for fusion cages.
3. Validated the product market fit.
4. Submitted a full patent surrounding this technology.
5. Submitted a journal paper reporting the development of 3D-printed spinal implants which is currently under review. In this study, we used the Fused Filament Fabrication (FFF) to 3D print a high-performance polymer known as Poly-ether-ketone (PEEK) for a load-bearing application. Specifically, we 3D printed resilient PEEK interbody fusion cages. However, FFF of PEEK structures is challenging because PEEK requires high melting temperatures and is prone to warping and incomplete crystallization, which negatively affect the strength of the fusion cages. Hence, for the first time, in this study, we varied critical FFF processing parameters such as nozzle, chamber, and bedplate temperature and analyze their influence on the cages' mechanical and thermal properties.
Last Modified: 09/01/2022
Modified by: Prabaha Sikder
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