RTI Surgical® Showcases SImmetry® System Data and TETRAfuse® 3D Technology at ISASS 2018
April 11 2018 - 8:23AM
Business Wire
Presentations underscore RTI’s growing focus on
next-generation spine implant technologies that are supported by
data and designed to help patient outcomes
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,ii suggesting 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.
Forward-Looking Statements
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.
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RTI Surgical, Inc.Media ContactsAnnie Claggett,
+1-312-995-2856aclaggett@rtix.comorMolly Poarch,
+1-224-287-2661mpoarch@rtix.comorInvestor ContactNathan
Elwell, +1-847-530-0249nelwell@lincolnchurchilladvisors.com
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