RTI Surgical® Showcases Advancements in Spine Portfolio and Clinical Data at NASS 2019
September 25 2019 - 7:05AM
RTI Surgical Holdings, Inc. (Nasdaq: RTIX), a global surgical
implant company, will showcase its expanding portfolio and body of
clinical data to reinforce the growing strength of its spine
business at the North American Spine Society’s (NASS) 34th Annual
Meeting in Chicago, September 25-28. RTI will feature its full line
of Established Therapies spine products and differentiated Novel
Therapies at booth #3815, including the recently launched
CervAlign® Anterior Cervical Plate System.
“RTI is proud to not only be a partner of choice for surgeons
with our comprehensive line of spine products and differentiated
specialty therapies backed by clinical data, but to also be able to
showcase our key platforms and growth drivers at NASS 2019,” said
Camille Farhat, President and CEO, RTI Surgical. “Over the last
five years, we have tripled the size of our spine business as we
bolstered our R&D pipeline and accelerated growth across our
Existing and Novel Therapies to treat more patients. We are
building an exciting future in the spine business.”
A Focus on Clinical Data and Product Activities
Interim Clinical Outcomes of the EVoluSIon Clinical Trial
for RTI’s SImmetry® Sacroiliac Joint Fusion System RTI has
completed enrollment for the EVoluSIon Clinical Trial evaluating
the impact of the SImmetry System on SI joint pain reduction on 250
patients. The company will release interim clinical outcomes in a
whitepaper at NASS on 150 patients who have reached their 6-month
follow-up. The EVoluSIon study evaluates pain and disability at 12-
and 24-month follow-up visits, as well as joint fusion rates. The
interim results of 150 patients at 6 months show:
- Mean Visual Analog Scale (VAS) SI joint pain decreasing from
77.2 at baseline to 33.3, a statistically significant reduction in
pain of 56%.
- Mean Oswestry Disability Index (ODI) scores improving from 54.1
at baseline to 32.8, a statistically significant and clinically
meaningful improvement in disability related to SI joint pain.
- A statistically significant decline in opioid use with 62% of
patients reporting taking opioids prior to surgery, and 34%
reporting taking opioids post-surgery – a decrease of 45%.
- A decrease in the use of non-opioid pain medications such as
NSAIDs, analgesics and steroids.
“The interim EVoluSIon data for 150 patients at six months
suggest pain reduction continues to be promising and, most notably,
the decrease in opioids and other pain medications points to an
emerging differentiator for the SImmetry System,” said Farhat.
Evaluation of the Fortilink® IBF Systems with TETRAfuse®
3D Technology (ENTRUST) Clinical Study Podium Presentation
Dr. Joseph O'Brien, Medical Director of Minimally Invasive
Orthopaedic Spine Surgery at the Washington Spine and Scoliosis
Institute at OrthoBethesda in Bethesda, Maryland, will present
outcomes from the ENTRUST clinical study on Wednesday, September
25, from 1:06-1:12 p.m. ENTRUST was a multi-center, post market,
retrospective study which collected safety and performance data for
patients implanted with the Fortilink®-C, -TS, and -L Interbody
Fusion (IBF) Systems with TETRAfuse® 3D Technology. Among the key
findings, the analysis of patients treated with the Fortilink IBF
Systems demonstrated the device is safe and results in improvements
in pain.
SImmetry® System Lab featured in NASS After Hours:
SI-Joint Hands-On Workshop On Wednesday, September 25, RTI
Surgical will participate in the “NASS After Hours: SI-Joint
Hands-On Workshop.” This NASS-sponsored program includes a didactic
session (3:30-5 p.m.) followed by a hands-on lab (5-8 p.m.) to
review the current state of SI joint dysfunction and the various
ways surgeons treat this condition, including the SImmetry®
Sacroiliac Joint Fusion System.
Cost Effectiveness Study Podium Presentation on
coflex® Interlaminar
Stabilization®
Dr. Jared Ament, a neurosurgeon in Rancho Palos Verdes, California,
will present “Cost-effectiveness of the coflex interlaminar
stabilization device: Evidence for increasing physician
reimbursement” during the Abstract Presentations: Thoracolumbar
Surgery V, on Thursday, September 26, between 3:35 and 5:05 p.m. in
Room W471ab.
Latest Advancements in RTI’s Spine
Portfolio
RTI will showcase its portfolio of hardware, biologic and
synthetic-based spinal implants at Booth #3815, including the
coflex® Interlaminar Stabilization® Device, the
SImmetry® Sacroiliac Joint Fusion System, Fortilink® Interbody
Fusion Systems with TETRAfuse® 3D Technology and ViBone® Viable
Bone Matrix.
Key highlights include:
- CervAlign ACP: RTI recently launched the
CervAlign® Anterior Cervical Plate (ACP) System to add to the
growth of its Established Therapies spine portfolio. The CervAlign
ACP System, organically developed by RTI, offers surgeons a plate
with a cover-style locking mechanism and streamlined
instrumentation and is designed to promote cervical fusion by
providing temporary resistance to flexion, extension, lateral
bending and axial rotation with strength and stiffness in the
cervical spine (C2-C7).
- SImmetry System Patient Website: RTI
updated the online presence of the SImmetry® Sacroiliac Joint
Fusion System with a website update for www.simmetrytherapy.com.
The site features enhanced patient education resources and
information for individuals who suffer from SI joint dysfunction to
learn about their needs and stay engaged through their entire
journey.
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 spine, sports medicine, general surgery, 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, visit
www.rtix.com. Connect with us
on LinkedIn and Twitter.
Molly PoarchInvestor
Contactmpoarch@rtix.com+1 224 287 2661
Steven CohenMedia
Contactscohen@rtix.com+1 847 648 0861
Forward-Looking Statements Portions of this
document may constitute “forward-looking statements” as defined by
federal law. Although the company believes any such statements are
based on reasonable assumptions, there is no assurance that actual
outcomes will not be materially different. Any such statements are
made in reliance on the “safe harbor” protections provided under
the Private Securities Reform Act of 1995. Additional information
about issues that could lead to material changes in performance is
contained in the company’s annual and quarterly reports filed with
the Securities and Exchange Commission.
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