RTI Surgical Enrolls First Patient in FORTE Clinical Study of Fortilink® Interbody Fusion Device with TETRAfuse® 3D Technology
DEERFIELD, Ill., March 20, 2019 (GLOBE NEWSWIRE) — 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
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scohen@rtix.com
Investor Contact:
Molly Poarch, RTI
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mpoarch@rtix.com
