April 11, 2018
ALACHUA, Fla.–(BUSINESS WIRE)–RTI Surgical, Inc. (Nasdaq: RTIX), a global surgical implant company, presented data on the SImmetry Sacroiliac Joint Fusion System at the International Society for the Advancement of Spine Surgery (ISASS) 2018 Annual Meeting taking place April 11-13, 2018 in Toronto, Canada. Data show the SImmetry System, the only minimally-invasive surgical procedure that promotes SI joint fusion through decortication, results in significant improvements in pain, disability and opioid use in patients suffering from SI joint dysfunction. RTI is also featuring the Fortilink®-C IBF System, the first in a series of devices to incorporate its TETRAfuse 3D Technology, used as an interbody fusion device in anterior cervical discectomy and fusion (ACDF) surgeries.
“These data add to the growing body of evidence supporting the SImmetry System as an innovative therapy for SI joint pain,” said Camille Farhat, President and CEO, RTI Surgical. “We look forward to sharing these data on the SImmetry System at ISASS, as well as showcasing Fortilink-C with TETRAfuse, our 3D-printed technology with unique features designed to enhance osseointegration and new bone formation.”
SImmetry Data: “Minimally Invasive Sacroiliac Joint Fusion Surgery with Decortication and Threaded Implants: Analysis of the EVoluSIon Clinical Study”
Dr. Ali Araghi from the Core Institute in Phoenix, Arizona, presented six-month clinical outcomes from 100 patients in the ongoing EVoluSIon Clinical Study. The EVoluSIon study is evaluating the impact of the SImmetry System on SI joint fusion and pain reduction in up to 250 patients at up to 40 sites. More than 200 patients have been enrolled to date.
Results showed the SImmetry System provided a 56 percent reduction in patient-reported pain, and a statistically significant reduction in the use of opioids and other pain medications at six months. The study also found a statistically significant improvement in disability and quality of life. These study results add to the growing body of evidence on the effectiveness of the SImmetry System and are consistent with the initial analysis published in December 2017.i
“We’re pleased to see these results – improvements in pain, disability, and opioid use – are consistent with earlier reported evidence,” Dr. Araghi commented. “We look forward to conducting longer term follow-up to evaluate continued pain reduction, hence an improved quality of life in our patients, as well as associated radiographic fusion rates.”
RTI Features Comprehensive Spine Portfolio at ISASS
RTI will showcase its comprehensive spine portfolio at Booth #412. A key feature will be the Fortilink-C IBF System with TETRAfuse 3D Technology. The Fortilink-C IBF System is the first 3D printed polymer-based, cervical interbody device featuring a nano-roughii surface with antibacterial characteristics†iii uniquely combined in one radiolucent bone-like material.ii The TETRAfuse 3D Technology is designed to participate in fusioniv without compromising mechanical integrityii or radiographic visibility,iisuggesting the Fortilink-C IBF System may be an important new option for surgeons commonly using titanium, allograft bone and PEEK systems.
The Fortilink-C IBF System has been available since October 2017. RTI is expanding its Fortilink series featuring TETRAfuse 3D Technology, aiming to launch new offerings later in 2018.
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, 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.
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 management’s 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 Araghi A et al. Pain and Opioid use Outcomes Following Minimally Invasive Sacroiliac Joint Fusion with Decortication and Bone Grafting: The Evolusion Clinical Trial. Open Orthop J. 2017;11:1440-1448.
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.
†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.
RTI Surgical, Inc.
Annie Claggett, +1-312-995-2856
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Nathan Elwell, +1-847-530-0249