RTI expands portfolio of spine implants
featuring differentiated spine technology designed to meet surgeon
needs and improve patient outcomes
RTI Surgical, Inc. (Nasdaq: RTIX), a global surgical implant
company, announced the full commercial launch of its Fortilink®-TS
and -L IBF Systems, adding to a growing series of interbody fusion
devices featuring proprietary TETRAfuse® 3D Technology. The
Fortilink-TS and -L Systems are intended for use in lumbar
interbody fusion procedures at one or two adjoining levels in
patients with degenerative disc disease. TETRAfuse 3D Technology is
the first 3D printed polymer-based interbody fusion device to
incorporate a nano-roughi surface that has demonstrated, in a
pre-clinical study, more notable trabecular bone ingrowth compared
to PEEK and titanium-coated PEEKii.
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Fortilink-TS IBF System, intended for
transforaminal lumbar interbody fusion (TLIF) or bilateral
posterior lumbar interbody fusion (PLIF) surgeries (Photo: Business
Wire)
“The Fortilink-L System is the first osteointegrative,
radiolucent cage,” said Joseph O'Brien, M.D., M.P.H., founder of
the Washington Spine & Scoliosis Institute at OrthoBethesda in
Bethesda, Maryland, and one of the first surgeons to implant the
Fortilink-L device. “While other companies are focusing on
titanium, TETRAfuse 3D Technology offers ingrowth features that
help the implant to fully integrate with the fusing bone. It also
has best-in-class X-ray compatibility, which allows me to track my
patients’ progress with more confidence.”
John O’Toole, M.D., M.S., Professor of Neurosurgery at Rush
University Medical Center in Chicago, Illinois, and one of the
first surgeons to implant the Fortilink-TS device, added, "The
introduction of TETRAfuse 3D
Technology revolutionizes the interbody device market
by combining a favorable modulus of elasticity, optimal
imaging characteristics and a surface
design promoting vigorous bone ingrowth. I believe
TETRAfuse 3D Technology meets all the criteria for an
interbody through enhanced biology, biomechanics and ease of use to
help improve outcomes for patients."
The Fortilink-L IBF System is intended for a lateral transpsoas
approach to the lumbar spine, also known as lateral lumbar
interbody fusion (LLIF) surgeries. The Fortilink-TS System is
intended for traditional posterior approaches known as
transforaminal lumbar interbody fusion (TLIF) or bilateral
posterior lumbar interbody fusion (PLIF) surgeries. TETRAfuse 3D
Technology features a nano-roughi surface with antibacterial
characteristics†iii and is designed to participate in fusionii
without compromising mechanical integrityi or radiographic
visibility.i
“Based on the positive feedback from our surgeon customers and
its unique design, we believe TETRAfuse 3D Technology is a new
frontier in spine surgery,” said Camille Farhat, President and CEO,
RTI Surgical. “RTI is committed to ongoing clinical research and
development of innovative spine-focused solutions that meet the
demands of surgeons and improve patient outcomes.”
RTI commercially launched its first implant using TETRAfuse 3D
Technology, the Fortilink-C IBF System, in October 2017. It is used
as an interbody fusion device in anterior cervical discectomy and
fusion (ACDF) surgeries. All Fortilink implants have received
510(k) clearance from the U.S. Food and Drug Administration
(FDA).
For more information about the Fortilink series of devices and
TETRAfuse 3D Technology, visit www.tetrafuse3D.com.
About Degenerative Disc Disease (DDD)
Degenerative disc disease (DDD) is an age-related condition when
one or more discs between the vertebrae of the spinal column
deteriorate or break down.iv A symptom of DDD can include low back
pain (LBP)iv, which is the most common musculoskeletal condition
affecting adults and the leading cause of disability worldwide.v
Approximately 40 percent of adults suffer from chronic low back
pain at some point in their lifetimevi, and health care costs and
productivity losses associated with it are more than $50 billion
annually.vii Spinal fusion surgery is considered a viable treatment
option for reducing pain and improving function in individuals
diagnosed with DDD and LBP, who have not found relief with
non-surgical care.viii
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 Data on file at RTI Surgical, Inc.ii Data on file at RTI
Surgical, Inc. Performance data from animal studies may not be
representative of performance in humans.iii Wang M, Bhardwaj B,
Webster T; Antibacterial properties of PEKK for orthopedic
applications. Int’l Journal of Nanomedicine. 2017: 12 6471-6476. iv
Donally C, Dulebohn S. Lumbar Degenerative Disk Disease.
StatPearls. Oct 2017. Online at
https://www.ncbi.nlm.nih.gov/books/NBK448134/. Last accessed May
25, 2018.v Allegri M, Montella S, Salici F, et al. Mechanisms for
low back pain: a guide for diagnosis and therapy. F1000Research.
Oct 2016. Online at
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4926733/. Last
accessed May 25, 2018.vi Manchikanti L, Singh V, Falco FJ, et al.
Epidemiology of low back pain in adults. Neuromodulation. 2014
Oct;17 Suppl 2:3-10. Online at
https://www.ncbi.nlm.nih.gov/pubmed/25395111. Last accessed May 25,
2018.vii Licciardone JC. The epidemiology and medical management of
low back pain during ambulatory medical care visits in the United
States. Osteopath Med Prim Care. 2008; 2: 11. Online at
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2631527/. Last
accessed May 25, 2018.viii Phillips FM, Slosar PJ, Youssef JA et
al. Lumbar spine fusion for chronic low back pain due to
degenerative disc disease: a systematic review. Spine (Phila Pa
1976). 2013 Apr 1;38(7):E409-22. Online at
https://www.ncbi.nlm.nih.gov/pubmed/23334400. Last accessed May 25,
2018.
†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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