RTI Surgical Holdings, Inc. (NASDAQ: RTIX), a global surgical
implant company, today announced it enrolled the first patient in
its Clinical Evaluation of Fortilink® Interbody Fusion Device with
TETRAfuse® 3D Technology in Subjects with Degenerative Disc Disease
(FORTE) study. FORTE is a prospective, multicenter post-market
evaluation of the safety and performance of the Fortilink-C, -TS,
and -L Interbody Fusion (IBF) Systems with TETRAfuse 3D Technology,
which recently won a 2018 Orthopedics This Week Spine Technology
Award. The primary objective of the study is to assess radiographic
evidence of cervical and lumbar fusion evaluated by an independent
core laboratory at 3-months post-surgery (Fortilink-C IBF System)
or 6-months post-surgery (Fortilink-TS and Fortilink-L IBF
Systems).
“I’ve really been impressed with the TETRAfuse implants so far,”
said Dr. K. Brandon Strenge, at The Orthopaedic Institute. “I’m
excited to see the bone growth showing on the CT scans, unlike the
titanium implants out there. The lateral implants have a great
variety of lordotic options and sizes to accommodate any situation
a surgeon may encounter.”
“While PEEK implants are widely used, data suggest PEEK has
minimal characteristics to enhance implant osseointegration,” said
Dr. Christopher Kepler, MBA, at The Rothman Orthopaedic Institute.
“The porous Fortilink cages with TETRAfuse 3D Technology have the
potential to create a favorable environment for bone growth and are
radiolucent. I look for the ongoing FORTE study to introduce
surgeons to this product and demonstrate the advantages of
Fortilink cages over other cage materials.”
The FORTE study will collect and evaluate real world data on
adult subjects with degenerative disc disease (DDD) to explore pain
reduction and procedural and long-term performance. The scope of
the study is to evaluate 150 patients at up to 20 sites in the U.S.
over the next 3.5 years, with evaluations post-procedurally at
intervals of 1,3, 6, 12 and 24 months for the purposes of study
data collection. All subjects are anticipated to be enrolled in Q1
2020.
“RTI is committed to providing innovative, safe and effective
spine solutions that are supported by clinical research,” said
Camille Farhat, President and CEO, RTI Surgical. “The FORTE study
aims to reinforce physician confidence and expand access for
patients by showing improved outcomes for appropriate DDD patients
based on the unique properties of TETRAfuse 3D Technology. We
believe TETRAfuse represents a new frontier in spine surgery with
its design to participate in fusion, and its bone-like mechanical
properties, radiolucency and antibacterial characteristics. Our
Fortilink series remains a key platform within our increasingly
differentiated spine portfolio, poised to drive growth for RTI in
2019 and beyond.”
TETRAfuse 3D Technology is an IBF device material that is
manufactured under an exclusive license agreement with Oxford
Performance Materials, Inc. (OPM), which grants RTI Surgical an
exclusive license to OPM’s technology for spinal applications in
the U.S. TETRAfuse 3D Technology is designed to help drive optimal
outcomes for patients undergoing spinal fusion procedures. For more
information about the Fortilink series of devices and TETRAfuse 3D
Technology, please 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.i A symptom of DDD can include low
back pain (LBP)i, which is the most common musculoskeletal
condition affecting adults and the leading cause of disability
worldwide.ii Approximately 40 percent of adults suffer from
chronic low back pain at some point in their lifetimeiii, and
health care costs and productivity losses associated with it are
more than $50 billion annually.iv 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.v
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. Connect with us
on LinkedIn and Twitter.
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.
References
i Donally C, Dulebohn S. Lumbar Degenerative Disk Disease.
StatPearls. 2017 Oct 13. Online at
https://www.ncbi.nlm.nih.gov/books/NBK448134/. Last accessed May
25, 2018.
ii 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.
iii 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.
iv 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.
v 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.
Media Contact: Steven Cohen, RTI +1 847 648
0861 scohen@rtix.com
Investor Contact: Molly Poarch, RTI +1 224 287
2661 mpoarch@rtix.com
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