Antibacterial Properties of OsteoFab® PEKK Implants Defined in New Research, Outperforming PEEK and Titanium

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We have been continually impressed with the strong bacteria resistance and pro-bone cell responses of OPM’s PEKK samples,” said Dr. Thomas Webster of Northeastern University. “All resulting from optimal surface properties without resorting to the use of antibiotics or the release of growth factors

Oxford Performance Materials, Inc. (OPM), an industry leader in advanced materials science and high performance additive manufacturing (HPAM®), today announced additional results of an ongoing scientific study analyzing the antibacterial properties of 3D printed PEKK (poly-ether-ketone-ketone). These new results definitively establish a mechanism of action for how 3D printed PEKK exhibits inherent antibacterial characteristics, further confirming PEKK’s role in combatting implant infections. In a continued partnership with Dr. Thomas Webster of Northeastern University, this research builds upon a September 2017 study(1) where samples produced by OPM’s proprietary OsteoFab® process “demonstrated for the first time the promise that nanostructured PEKK has for numerous anti-infection orthopedic implant applications.”

In a second set of experiments conducted by Dr. Webster in December 2019, it was determined that 3D printed PEKK demonstrated significant reductions for all bacteria colonization(2) when measured via colony forming units, crystal violet staining, and live/dead assays. This was true for all tested bacteria strains, which included S. epidermidis, P. aeruginosa, and MRSA, and all tested materials, as 3D printed PEKK significantly outperformed commercially available titanium and PEEK controls. This study was important for two primary reasons: it confirmed the results seen in the 2017 study(1) in the presence of titanium and PEEK controls and it raised the question of why PEKK is superior in this aspect, hinting that 3D printed PEKK may have a biologically optimal surface energy in the context of bacterial aversion.

In April of 2020, a follow-up study was conducted to determine the mechanisms of the antibacterial properties of 3D printed PEKK after 24 hours of culture, specifically examining protein adsorption and correlating that adsorption to bacteria response. Based on the test results(2), 3D printed PEKK exhibited a surface energy (35.7 mN/m) that was much closer to proteins lubricin (40 mN/m), mucin (42-46 mN/m), and casein (48 mN/m), which are all proteins known to reduce bacteria attachment and colonization naturally in vivo. When compared to the surface energies of PEEK (16.3 mN/m) and titanium (62.5 mN/m), it was evident 3D printed PEKK is optimal in terms of similarity to these naturally occurring proteins. As expected, the experiment showed greater protein adsorption of lubricin, mucin, and casein on PEKK in comparison to PEEK and titanium controls.

This greater protein adsorption was then correlated to greater bacteria inhibition of 3D printed PEKK compared to commercially available PEEK and titanium. For this portion of the study, samples were coated with lubricin, mucin, and casein, and bacteria attachment was characterized using colony forming unit counts, crystal violet staining, and live/dead assays. All results correlated the increased protein adsorption to decreased bacteria colonization for S. epidermidis, P. aeruginosa, and MRSA, again compared to PEEK and titanium controls.

This finding is extremely important as it provides objective evidence explaining why OPM’s 3D printed PEKK exhibits inherent antibacterial effects. “We have been continually impressed with the strong bacteria resistance and pro-bone cell responses of OPM’s PEKK samples,” said Dr. Webster. “All resulting from optimal surface properties without resorting to the use of antibiotics or the release of growth factors, as our studies have shown.” Equally significant are the implications of lubricin adsorption onto 3D printed PEKK, in terms of future joint and cartilage applications of the OsteoFab technology platform. Lubricin is a naturally occurring protein that is secreted in synovial joints; it coats surrounding cartilage and contributes to the overall integrity of the joint. With demonstrated adhesion to 3D printed PEKK, new devices could provide even more benefits in an increasing number of orthopedic applications.

The antibacterial attributes of 3D printed PEKK are significant since they address a key area of growing concern in medicine – orthopedic implant infections. 3D printed PEKK’s antibacterial properties, as detailed in this new study, will provide another important layer of differentiation for the performance of OsteoFab medical devices in the marketplace. Results from these experiments will be available in a forthcoming publication.

About Oxford Performance Materials, Inc.

Oxford Performance Materials, Inc. was founded in 2000 to exploit and commercialize the world’s highest performing thermoplastic, PEKK (poly-ether-ketone-ketone). OPM’s Materials business has developed a range of proprietary, patented technologies for the synthesis and modification of a range of PAEK polymers that are sold under its OXPEKK® brand for biomedical and industrial applications. The Company is a pioneer in 3D printing. OPM Biomedical’s OsteoFab® technology is in commercial production in numerous orthopedic implant applications, including cranial, facial, spinal, and sports medicine devices. OPM is the first and only company to receive FDA 510(k) clearance to manufacture 3D printed, patient-specific polymeric implants, and the company has six 510(k) clearances in its portfolio. OPM Industrial produces 3D printed OXFAB® production parts for highly demanding applications in the energy, transportation, and semiconductor markets. OXFAB® structures offer significant weight, cost, and time-to-market reductions that are defined in a set of specified performance attributes in the exhaustive OPM B-Basis database, developed in conjunction with NASA. For more information, please visit: http://www.oxfordpm.com

References

“Antibacterial Properties of PEKK for Orthopedic Applications,” International Journal of Nanomedicine, Dovepress 15-Sep-2017, Mian Wang, Garima Bhardwaj (Department of Chemical Engineering, Northeastern University, Boston MA) and Thomas J. Webster (Department of Chemical Engineering, Northeastern University, Boston MA and Wenzhou Institute of Biomaterials and Engineering, Wenzhou Medical University, Wenzhou, China). The full study by Mian Wang, et al. may be viewed at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5592909/

2. https://oxfordpm.com/uploads/files/OPM-T._Webster_AM_Med_Summit_19Oct2020_website.pdf?v=1605303394194

Company Contact:

Bernie Plishtin

Oxford Performance Materials

860-656-9446

bplishtin@oxfordpm.com

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