OPM's OsteoFab® 3D printed PEKK Technology in Study Published in Nature

SOUTH WINDSOR, Conn., June 20, 2019 /PRNewswire-PRWeb/ -- Oxford Performance Materials, a pioneer in advanced materials science and high-performance additive manufacturing (HPAM®), announced today exciting results of a McGill University research study recently published in Nature(2) that establish a definitive link between OPM's 3D printed PEKK material and bone regeneration. In vitro results of the study demonstrate the ability of human synovial fluid mesenchymal stem cells to attach, proliferate, and differentiate on PEKK scaffolds, and in vivo results show strong evidence of new bone formation.

OPM has long had strongly indicative data that its' OsteoFab 3D printed PEKK technology has a highly desirable bone response. Early in vitro studies (circa 2010) had indicated a positive and exciting cellular response to 3D printed PEKK when compared to control materials, which prompted further investigation. Subsequent in vivo studies that examined tissue response to 3D printed PEKK implants in an osseous environment (rabbit model, circa 2013) showed that native PEKK material supported bone apposition. Interestingly, and unlike commonly used PEEK material, OsteoFab 3D printed PEKK showed no observable immunological rejection and no increase in inflammatory response cells. What was attributed to PEKK's unique chemistry and the inherent surface roughness of OsteoFab 3D printed PEKK has since led to a number of additional studies and clinical applications.

Shifting from studying the bulk implant material to latticed, scaffold structures, OsteoFab 3D printed PEKK scaffolds were similarly examined in in vitro and in vivo experiments. In 2014, a funded research study demonstrated the successful growth of bone marrow cells on 3D printed PEKK scaffolds and since then, a number of publications have examined the use of mesenchymal stem cells (autologous, adipose-derived, and human synovial fluid-derived) on PEKK scaffolds in critical sized defects. In 2016, Adamzyk et al.(3) studied the use of PEKK scaffolds with autologous mesenchymal stem cells in a sheep calvarial defect model and found that 3D printed PEKK scaffolds allowed for the adherence, growth, and osteogenic differentiation of human and ovine stem cells, with considerable amounts of newly formed bone in all PEKK groups. In 2017, Roskies et al.(4) similarly studied 3D printed PEKK scaffolds with adipose-derived stem cells for the reconstruction of critical sized mandibular defects. This group determined that the PEKK scaffolds presented a promising solution to improve bone-implant interfaces and biomechanical attributes of implanted materials.

Later in 2017, in a paper published by Wang et al. in the International Journal of Nanomedicine(5) , OsteoFab 3D printed PEKK was also shown to possess antibacterial properties when compared to conventional PEEK material. This in vitro study indicated decreased adhesion and growth of common bacterial strains on the rough PEKK surface when compared to a PEEK control, suggesting the need for additional studies of 3D printed PEKK in a wide range of antibacterial orthopedic applications.

With this body of work and the functionalizing of 3D printed PEKK scaffolds culminating into the recent publication in Nature, one fact has remained constant; that regardless of stem cell seeding or defect model, native 3D printed PEKK test groups have demonstrated bone apposition, bone ingrowth, and improved biomechanical properties, making OsteoFab 3D printed PEKK a more desirable and functional implant material.

With the amount of literature growing around the use and application of OsteoFab 3D printed PEKK technology, the clinical possibilities are also growing. Since 2013, OPM has been manufacturing patient-specific cranial and facial implant devices that have been distributed world-wide. In addition to over 2,000 craniomaxillofacial implants, OPM has also 3D printed tens of thousands of spinal implants under a number of 510(k) clearances. As the need for clinically robust, all-encompassing solutions grows, OsteoFab® 3D printed PEKK is there to meet the demand.

About Oxford Performance Materials, Inc.
Oxford Performance Materials 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, aerospace, 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 and spinal devices. OPM is the first and only company to receive FDA 510(k) clearance to manufacture 3D printed patient-specific polymeric implants, and has five 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
1.    Lin, Y., Umebayashi, M., Abdallah, M., Dong, G., Roskies, M., & Zhao, Y. et al. (2019). Combination of polyetherketoneketone scaffold and human mesenchymal stem cells from temporomandibular joint synovial fluid enhances bone regeneration. Scientific Reports, 9(1). doi: 10.1038/s41598-018-36778-2
2.    Scientific Reports 9, Article number: 472 (2019)
3.    Adamzyk, C., Kachel, P., Hoss, M., Gremse, F., Modabber, A., & Hölzle, F. et al. (2016). Bone tissue engineering using polyetherketoneketone scaffolds combined with autologous mesenchymal stem cells in a sheep calvarial defect model. Journal Of Cranio-Maxillofacial Surgery, 44(8), 985-994. doi: 10.1016/j.jcms.2016.04.012
4.    Roskies, M., Fang, D., Abdallah, M., Charbonneau, A., Cohen, N., & Jordan, J. et al. (2017). Three-dimensionally printed polyetherketoneketone scaffolds with mesenchymal stem cells for the reconstruction of critical-sized mandibular defects. The Laryngoscope, 127(11), E392-E398. doi: 10.1002/lary.26781
5.    Wang, M., Bhardwaj, G., & Webster, T. (2017). Antibacterial properties of PEKK for orthopedic applications. International Journal Of Nanomedicine, Volume 12, 6471-6476. doi: 10.2147/ijn.s134983

SOURCE Oxford Performance Materials