RTI Surgical, Inc. (Nasdaq: RTIX), a global surgical implant company, will showcase research reinforcing the strength of its spine portfolio, notably the Fortilink IBF series featuring TETRAfuse 3D Technology, at the North American Spine Societys (NASS) 33rd Annual Meeting in Los Angeles, September 26-29. Additionally, RTI will feature its full line of hardware, interbody and orthobiologic offerings at Booth #1523, including its newest orthobiologic options, ViBone Viable Bone Matrix and the next generation of the nanOss Advanced Bone Graft Substitute (ABGS) series, nanOss 3D Plus„¢ ABGS.
As evidenced by our presence at NASS this year, RTI is shaping the future of spinal technologies to power mobility with targeted innovation and a portfolio focused on differentiated products supported by clinical data, said Camille Farhat, President and CEO, RTI Surgical. We are advancing and growing our full line of high-quality spine offerings, expanding RTIs body of clinical data to optimize outcomes, and pursuing next-generation technologies to meet the diverse needs of surgeons and spine patients.
TETRAfuse 3D Technology and ViBone Clinical Data Featured in Innovative Technology Presentations
Boyle Cheng, PhD, Director of Research in Neurosurgery at Allegheny General Hospital in Pittsburgh, will present outcomes from a comparative pre-clinical study evaluating in vivo osseointegration with smooth surface polyetheretherketone (PEEK), titanium-coated rough PEEK and TETRAfuse 3D Technology in an ovine bony defect model. Among the key findings, the study showed TETRAfuse 3D Technology demonstrated more notable trabecular bone ingrowth compared to PEEK and titanium-coated PEEK.i
In the same session, Dean E. Smith, MD, from the Spine Center in El Paso, Texas, will present findings from an in vitro evaluation and a retrospective study of clinical outcomes in patients undergoing lumbar and cervical fusion using ViBone. The in vitro evaluation demonstrated better cell health in ViBone, including lower apoptotic activity, better cellular proliferation, as well as greater production of osteogenic markers, than control viable bone matrix.
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Latest Advancements in RTIs Portfolio
RTI will showcase its comprehensive portfolio of high-quality hardware, interbody and orthobiologic options at Booth #1523. Key highlights include:
- ViBone: RTI recently signed an agreement under which Aziyo Biologics, Inc., will provide ViBone to RTI for exclusive distribution in the U.S. ViBone is a viable bone product designed to perform and handle more closely to autograft in a variety of orthopedic procedures.
- nanOss 3D Plus ABGS: RTI launched nanOss 3D Plus ABGS, a new addition to its nanOss ABGS series, designed with innovative technology and supported by clinical results,ii to provide optimal handling properties for a variety of orthopedic procedures.
Clinical Trial Updates
- The SImmetry System: RTI is pleased to share the final patient has been recruited in the ongoing EVoluSIon Clinical Study. EVoluSIon is evaluating the impact of the SImmetry System on sacroiliac (SI) joint fusion and pain reduction in patients with SI joint dysfunction who have not gained relief from conservative care. A total of 250 patients are participating in the trial across 23 sites. RTI plans to share the latest outcomes analysis in early 2019.
- Fortilink-C, -TS, -L IBF Systems: RTI intends to initiate patient enrollment later this year for a prospective, multi-center post-market evaluation of safety and performance of the Fortilink-C, -TS, and -L IBF Systems with TETRAfuse 3D Technology. The study, titled FORTE: Clinical Evaluation of Fortilink TETRAfuse Interbody Fusion Device in Subjects with Degenerative Disc Disease, aims to enroll up to 150 patients at up to 25 sites. The study will assess radiographic evidence of fusion assessed by an independent core laboratory, pain reduction, and procedural and long-term success of the Fortilink C, -TS, and -L IBF Systems.
About RTI Surgical, 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, RTIs 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.
This communication contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on managements current expectations, estimates and projections about our industry, our management’s beliefs and certain assumptions made by our management. Words such as “anticipates,” “expects,” “intends,” “plans,” “believes,” “seeks,” “estimates,” variations of such words and similar expressions are intended to identify such forward-looking statements. In addition, except for historical information, any statements made in this communication about anticipated financial results, growth rates, new product introductions, future operational improvements, gaining market share and results or regulatory actions or approvals or changes to agreements with distributors also are forward-looking statements. These statements are not guarantees of future performance and are subject to risks and uncertainties, including the risks described in public filings with the U.S. Securities and Exchange Commission (SEC). Our actual results may differ materially from the anticipated results reflected in these forward-looking statements. Copies of the company’s SEC filings may be obtained by contacting the company or the SEC or by visiting RTI’s website at www.rtix.com or the SEC’s website at www.sec.gov.
i Data on file at RTI Surgical, Inc. Performance data from animal studies may not be representative of performance in humans. ii Data on file at RTI Surgical, Inc.