RTI Surgical® Announces The Spine Journal’s Publication of In Vivo TETRAfuse® 3D Technology PEKK Study

RTI Surgical Holdings, Inc. (Nasdaq: RTIX), a global surgical implant company, today announced the publication of “A Comparative Study of Three Biomaterials in an Ovine Bone Defect Model: A TETRAfuse® PEKK Study” in The Spine Journal1. The study evaluated the in vivo material characteristics of Polyetheretherketone (PEEK), Titanium-coated PEEK (Ti-coated) and 3D-printed Polyetherketoneketone (PEKK), TETRAfuse® 3D Technology.

PEEK, and more recently Ti-coated PEEK, have been used as conventional biomaterial design choices for spinal interbody implants. However, shortcomings in these materials, such as surface delamination and lack of bone apposition, necessitated further research into additional interbody material constructs, such as TETRAfuse 3D Technology. TETRAfuse 3D Technology is featured in the growing family of RTI’s Fortilink® Interbody Fusion Systems and has a nano-roughii surface with antibacterial characteristics†iii designed to participate in fusioniv without compromising mechanical integrityii or radiographic visibilityii.

“This study provided evidence of the potential advantages of TETRAfuse 3D Technology related to bone growth characteristics without sacrificing structural integrity,” said Dr. Boyle C. Cheng, PhD, Director of Research in Neurosurgery at Allegheny General Hospital in Pittsburgh. “In the ovine model, histological review of TETRAfuse 3D Technology samples showed deeper implant osseointegration and more notable trabecular bone ingrowth. There is compelling evidence that PEKK offers preferable characteristics to the more conventional interbody materials.”

Implants were analyzed post-implantation at 8 and 16 weeks with respect to their osseointegrative capacities using a push-out method, histological staining and various radiographic tests. Study resultsv showed TETRAfuse 3D Technology implants demonstrating bone ingrowth, no radiographic interference, no fibrotic tissue membrane formation, a significant increase in bony apposition over time, and a significantly higher push-out strength compared to standard PEEK.

“The data from this hallmark ovine study in The Spine Journal indicate TETRAfuse 3D Technology’s unique potential to improve the effectiveness of spinal fusion procedures,” said Camille Farhat, President and CEO, RTI Surgical. “We believe there are significant opportunities for TETRAfuse to positively impact fusion, pain reduction and long-term performance. We continue to invest in the clinical data for this innovative interbody device material, including our ongoing FORTE study, to demonstrate its preferred characteristics and the positive impact it could have for spine patients.”

In June 2019, RTI announced a milestone of 5,000 implants of Fortilink®-C, -TS and -L IBF Systems with TETRAfuse 3D Technology in the United States. TETRAfuse 3D Technology recently won a 2019 MedTech Breakthrough Award for “Best New Technology Solution - Orthopedics” and a 2018 Spine Technology Award from Orthopedics This Week. For more information, please visit www.tetrafuse3D.com.

References

i Cheng, PhD B, Jaffee S, Swink I, Averick, PhD S, Horvath S, Zhukauskas, PhD R et al. A Comparative Study of Three Biomaterials in an Ovine Bone Defect Model: A TETRAfuse® PEKK Study. The Spine Journal. 2019. doi: 10.1016/j.spinee.2019.10.003

ii Data on file at RTI Surgical, Inc.

iii Wang M, Bhardwaj B, Webster T; Antibacterial properties of PEKK for orthopedic applications. Int’l Journal of Nanomedicine. 2017: 12 6471-6476.

iv Data on file at RTI Surgical, Inc. Performance data from animal studies may not be representative of performance in humans.

v Industry funding was provided for the completion of this research study, followed by an independent third-party review of all relevant data for publication.

† Lab data may not be representative of the effects with all bacteria or performance when implanted in humans. Staphyloccocus epidermidis and Pseudomonas aeruginosa were subject bacterial strains in this study.

Please refer to the labeling for clinical applications, warnings, precautions and other instructions for use.

About RTI Surgical Holdings, Inc.

RTI Surgical is a leading global surgical implant company providing surgeons with safe biologic, metal and synthetic implants. Committed to delivering a higher standard, RTI’s implants are used in sports medicine, general surgery, spine, orthopedic and trauma procedures and are distributed in nearly 50 countries. RTI has four manufacturing facilities throughout the U.S. and Europe. RTI is accredited in the U.S. by the American Association of Tissue Banks and is a member of AdvaMed. For more information, please visit www.rtix.com. Connect with us on LinkedIn and Twitter.

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