RTI Surgical® Releases Data on the SImmetry® System Showing 98% of Treated SI Joints Demonstrate Evidence of Fusion
February 26 2020 - 7:00AM
RTI Surgical Holdings, Inc. (Nasdaq: RTIX), a global surgical
implant company, will showcase its expanding body of clinical data
on the SImmetry® Sacroiliac Joint Fusion System at the 2020
International Society for the Advancement of Spine Surgery (ISASS)
meeting in San Juan, Puerto Rico, from February 26-28. The interim
results on 50 patients at 24 months in the EVoluSIon study indicate
98 percent of treated joints show evidence of fusion and 78 percent
of patients are opioid-free, reinforcing the importance of
decortication as part of the SImmetry System procedure to drive
fusion and pain relief for patients with SI joint dysfunction.
“In my experience using the SImmetry System, I have observed it
follows true orthopedic principles for fusion with decortication,
bone grafting and fixation,” said Dr. Donald Kucharzyk of DK
Orthopedics in Crown Point, Indiana. “It is reproducible and
consistent in its technique case after case, even with anatomic
variations. Patients feel the difference immediately. These interim
EVoluSIon study results reveal a significant reduction in opioid
use from baseline, significant improvements in activity levels, and
compared to the previous literature published, compelling evidence
of fusion.”
Latest Interim Clinical Outcomes in the EVoluSIon
Study
RTI will release interim clinical outcomes on 50 patients who
have reached their 24-month follow-up in the EVoluSIon study
through a podium presentation, “Clinical and Radiographic Outcomes
Following Minimally Invasive Sacroiliac Joint Fusion Surgery with
Decortication,” on February 26 from 2:20 - 2:25 p.m. in Room 208 by
Dr. Donald Kucharzyk.
The interim results of 50 patients at 24 monthsi show:
- 98% of treated joints with evidence of fusion, with 84% showing
solid fusion and 14% showing possible fusion. Solid fusion was
defined as presence of a continuous segment of solid bridging bone
that extends from the sacrum to the ilium.
- A statistically significant decline in opioid use of 65% from
baseline, with 78% of patients opioid-free at 24 months.
- Mean Visual Analog Scale (VAS) SI joint pain decreasing from
75.2 at baseline to 30.1, a statistically significant reduction in
pain of 60%.
- Mean Oswestry Disability Index (ODI) scores improving from 55.2
at baseline to 26.9, a statistically significant reduction of 51%
and clinically meaningful improvement in disability related to SI
joint pain.
“Interim EVoluSIon study data continue to show that joint
decortication as part of the SImmetry System helps to achieve real
fusion, which supports reduced opioid use and significant pain
relief,” said Camille Farhat, President and CEO, RTI Surgical. “As
we progress toward our future as a more focused spine company, RTI
is committed to offering surgeons a growing portfolio of
differentiated clinical solutions and therapies backed by data to
deliver better outcomes for patients.”
The EVoluSIon study will continue to evaluate pain and
disability at 12- and 24-month follow-up visits, as well as joint
fusion rates, which is expected to define similarities or further
distinctions between different types of implants for the SI
joint.
RTI will also feature its Established Therapies spine products
and differentiated Novel Therapies at booth #400, including
portfolio growth-drivers TETRAfuse® 3D Technology, ViBone® Viable
Bone Matrix, coflex® Interlaminar Stabilization® and the SImmetry
System. The Company will also host a Lunch Workshop with Dr.
Scott Blumenthal, Texas Back Institute, Dallas, Texas, Dr.
Celeste Abjornson, Hospital for Special Surgery, New York, New
York, and Dr. Donald Kucharzyk. Titled “The Role of
Differentiated Technologies in the Spine Surgeon's Practice,” the
workshop will take place Thursday, February 27, from noon to 1:30
p.m. in Room 209B.
Referencesi Data on file with RTI Surgical
Molly Poarch Investor Contact mpoarch@rtix.com
+1 224 287 2661
Steven Cohen Media Contact scohen@rtix.com +1
847 648 0861
About RTI Surgical Holdings, Inc. RTI Surgical
Holdings 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, plastic surgery, spine, orthopedic and trauma
procedures and are distributed in over 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.
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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