ALACHUA, Fla.–(BUSINESS WIRE)–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-roughⁱsurface that has demonstrated, in a pre-clinical study, more notable trabecular bone ingrowth compared to PEEK and titanium-coated PEEKⁱⁱ.

“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 lifetime^vi, 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.

CASTEL SAN PIETRO, Switzerland–(BUSINESS WIRE)–Family-owned orthopedics leader Medacta International today announced the first surgery utilizing its Medacta Unconstrained Screw Technology Sacro-Iliac Joint Screw System (M.U.S.T. SI) for sacroiliac joint fusion surgery, following clearance by the U.S. Food and Drug Administration (FDA). The M.U.S.T. Sacro-Iliac Joint Screw System is designed for sacroiliac joint fusion for patients suffering from degenerative sacroiliitis, sacroiliac joint disruptions and degenerative sacroiliac arthritis to ease chronic back pain. The system’s corresponding procedure is minimally invasive and can be optimized for the outpatient surgical setting. The first surgery employing M.U.S.T. SI in the U.S. was performed by Ashish Sahai, M.D., at West Boca Medical Center, in Boca Raton, Florida in mid-May.

Dr. Sahai’s patient had adjacent segment degeneration in the lumbar spine, secondary to previous lumbosacral fusion. “The M.U.S.T. SI provided a niche solution that was the best fit for my patient’s unique case,” said Dr. Sahai of the surgery. “I was impressed with the solid engagement the M.U.S.T. SI system provided, with strong stability in the interface between the system and its dedicated instrumentation. The added stability instilled greater confidence in the OR that my screw trajectory would be as accurate as possible, and my patient is doing extremely well as a result.”

The M.U.S.T. SI system features screws coated with porous and rough hydroxyapatite that are designed with hollow-body and multiple fenestrated patterned shafts to promote biological fixation and optimal arthrodesis. The self-tapping screws have radial windowed slots to optimize surrounding bone access to the bone substitute, allowing greater bone growth; a long pitch and dual lead thread for accelerated screw insertion and removal; and a tapered tip to aid in guidance through the pilot hole. The system also offers “one-size-fits-all” washers with favored angles, capable of accommodating extreme angulation and allowing optimal compression, as well as a comprehensive range of lengths suited for diverse patient anatomies.

“The M.U.S.T. SI System addresses another area of spine impairment, allowing us to continue enhancing our already comprehensive spine portfolio and build out our offerings that are well suited for both traditional and outpatient settings,” said Francesco Siccardi, Executive Vice President, Medacta International. “Congratulations to Dr. Sahai and team on a successful surgery; we’re always thrilled to see positive patient outcomes and look forward to rolling out this effective product throughout the U.S.”

M.U.S.T. SI is the newest addition to the M.U.S.T. Screw System portfolio, designed to deliver flexibility and versatility for surgeons. When paired with Medacta’s MectaLIF family of inter-body fusion devices and suite of specialized surgical instruments, the result is a harmonized, single-system approach for most spine stabilization applications.

For more information, visit Medacta’s M.U.S.T. SI webpage.

About Medacta International

Medacta^® International is a world leading manufacturer of orthopedic implants, neurosurgical systems, and instrumentation. Medacta’s revolutionary approach and responsible innovation have resulted in standard of care breakthroughs in hip replacement with the AMIS^® system and total knee replacement with MyKnee^® patient matched technology. Over the last 10 years, Medacta has grown dramatically by taking a different approach and placing value on all aspects of the care experience from design to training to sustainability. Medacta is headquartered in Castel San Pietro, Switzerland, and operates in over 30 countries. To learn more about Medacta International, please visit www.medacta.com or follow @Medacta on Twitter.

LITTLE ROCK, Ark.–(BUSINESS WIRE)–CoreLink, LLC (“CoreLink”), a portfolio company of The Stephens Group, LLC, has acquired the assets of Expanding Orthopedics, Inc. Terms of the transaction were not disclosed.

Expanding Orthopedics, founded in 2001, develops and commercializes innovative expandable devices for minimally invasive spine surgery. Along with the FDA-cleared expanding and articulating FLXfit™ and FLXfit 15™ titanium interbody systems, CoreLink has also acquired a broad array of additional patents and in-development products addressing the rapidly growing expandable interbody and spinal fusion market. CoreLink will provide enhanced support for existing users of both the FLXfit and FLXfit 15 systems, while utilizing its unique vertical integration to quickly incorporate system upgrades for a full commercial re-launch in Q3 2018.

“The acquisition of Expanding Orthopedics allows us to better serve our customers’ needs by adding important product lines and intellectual property in the fastest growing categories within the spine market. We look forward to supporting Expanding Orthopedics’ existing customer base with CoreLink’s broader product offering and leading sales, training, distribution and manufacturing infrastructure, and we’re particularly excited to introduce these new product lines to CoreLink’s customers,” said Jay Bartling, founder and CEO of CoreLink.

Clay Hunter, Managing Director at The Stephens Group, added, “We are very pleased to support CoreLink in this first complementary acquisition which adds a high-growth product line to CoreLink’s already broad portfolio. Jay and his team are great partners, and we look forward to continuing to support their efforts to build the leading vertically integrated manufacturer and distributor of highly engineered spinal implants and instrumentation.”

ABOUT CORELINK, LLC
Headquartered in St. Louis, Missouri, CoreLink is a leading provider of medical devices, primarily highly engineered spinal implants and instrumentation. The company employs both traditional precision manufacturing and additive manufacturing techniques to produce and sell a broad and growing line of pedicle screw systems, interbody spacers, plates, biologics and surgical instruments through a network of distributors and independent sales representatives as well as its internal salesforce to hospitals, surgery centers and other healthcare providers.

ABOUT THE STEPHENS GROUP, LLC
The Stephens Group is a private, family-owned firm investing its capital in companies with exceptional management teams and high returns on invested capital in growing industries. The Stephens Group has a long history of successfully investing in both minority and control positions across multiple industries. The Stephens Group, through its affiliates, has or has had significant investments in industrial products and services, healthcare, specialty distribution, telecom, media and technology, communications, financial services, consumer and specialty retail, energy services and gas exploration and production and other industries.