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Development and Pre-Clinical Testing of PEKK/Silicon Nitride Composite Craniomaxillofacial Implants

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R43DE031456-01
Agency Tracking Number: R43DE031456
Amount: $299,980.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: NIDCR
Solicitation Number: PA20-260
Solicitation Year: 2020
Award Year: 2022
Award Start Date (Proposal Award Date): 2022-03-10
Award End Date (Contract End Date): 2023-03-09
Small Business Information
1885 W 2100 S
Salt Lake City, UT 84119-1303
United States
DUNS: 028629553
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (805) 252-2048
Business Contact
Phone: (805) 252-2048
Research Institution

PROJECT SUMMARY—Over 235,000 Americans undergo craniomaxillofacial (CMF) surgery annually, with
implant failure rates averaging 5.5% in general and up to 37% and 52% in the orbital and temporal regions,
respectively. Failures are attributed to prosthetic infections, poor osseointegration, corrosion, and fracture. Most
can be linked to implant materials that underperform in terms of bioactivity, infection control, osseous integration,
or mechanical stability. Thus, there continues to be a critical clinical need for medical imaging compatible
3DP biomaterials for craniomaxillofacial osteoplasty that can be personalized, promote integration, and
prevent infection. SINTX Technologies, Inc. pioneered the use of silicon nitride (Si3N4) as a high-performance
alternative to metal and polymer-based biomaterials for bone and joint repair. Si3N4 is a promising biomaterial
for CMF defects because of its antibacterial activity, osseointegration, radiographic imaging, and durability, but
the stiffness of Si3N4 engenders stress shielding and may be susceptible to subsidence and brittle fracture. In
contrast, PEEK and PEKK are more flexible, radiotransparent biomaterials, but these polymers lack antimicrobial
and osseointegrative properties. To overcome these limitations, SINTX proposes to combine its bioactive Si3N4
with PEKK to form a 3D-printable composite that will be radiolucent, possess an elastic modulus similar to cortical
bone, and simultaneously provide improved antimicrobial and osteointegration properties. The purpose of this
application is to design, build, and test 3DP PEKK/Si3N4 composite for non-load-bearing CMF implants that
satisfy material requirements and enhance infection resistance and osseous integration. Aim 1. Design,
produce, and characterize porous 3DP PEKK/Si3N4 implants for non-load-bearing CMF applications.
Milestones: 1) Prepare PEKK/Si3N4 composite filaments based on a range of PEKK/Si3N4 volume ratios; 2)
Design an appropriate CMF implant based on the amount and type of included porosity; 3) Validate the 3D
printability of the various PEKK/Si3N4 composites; and 4) Assess the physical and mechanical properties of the
3DP CMF composite designs. Aim 2. Complete in vitro antibacterial and osteoconductivity testing of the
preferred 3DP PEKK/Si3N4 implant from Aim 1. Milestones: Demonstrate that test components from the
preferred 3DP PEKK/Si3N4 implant 1) Achieve a ≥ 1.5-log10 reduction in Staphylococcus epidermidis (S.
epidermidis) and Escherichia coli (E. coli); and 2) demonstrate an ability to significantly upregulate osteoblastic
activity. Aim 3. Test the in vivo antimicrobial effectiveness and overall healing of the 3DP PEKK/Si3N4
implant compared to PEEK. Milestones: 1) Prepare and characterize identical 3DP partially porous PEKK/Si3N4
and PEEK implants; and 2) Complete a 28-day in vivo time-course study of these implants under aseptic and
septic conditions in Wistar rats. Impact – This proof-of-concept project is expected to provide strong rationale
and preliminary data to support further study and commercialization of a 3D-printable PEKK/Si3N4 composite for
CMF implants, which could substantially reduce implant failures due to infection and/or poor bone integration.

* Information listed above is at the time of submission. *

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