News


RTI Surgical® Showcases Advancements in Spine Portfolio and Clinical Data at NASS 2019

Molly Poarch
Investor Contact
mpoarch@rtix.com
+1 224 287 2661

Steven Cohen
Media Contact
scohen@rtix.com
+1 847 648 0861

RTI announces interim clinical outcomes on 150 patients at 6-month follow-up in the EVoluSIon study for the SImmetry® Sacroiliac Joint Fusion System showing statistically significant reductions in pain of 56% and opioid use of 45%

Chicago, Ill. – September 25, 2019 – 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 OrthoBesthesda in Bethesda, Maryland, will present outcomes from the ENRTUST 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.

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.


Contacts

    Molly Poarch
    Director, Corporate Communications
    mpoarch@rtix.com
    +1 224 287 2661

    Steve Cohen
    Manager, Corporate Communications (Spine)
    scohen@rtix.com
    +1 847 648 0861

    Andrea Johnson
    Manager, Corporate Communications (Sports Medicine, OEM, Donor Services & International)
    amjohnson@rtix.com
    +1 630 518 5345

    Jessica Rumschlag
    Executive Assistant, Investor Relations
    jrumschlag@rtix.com
    +1 630 652 5909