ST. PAUL, Minn.–(BUSINESS WIRE)–Spineology Inc., an innovator in anatomy-conserving spine surgery, is excited to announce that John Chi, M.D., M.P.H, Associate Professor of Neurosurgery at Harvard Medical School and the Director of Neurosurgical Spinal Oncology at Brigham and Women’s Hospital in Boston MA, has presented the first 12-month outcomes data from Spineology’s SCOUT clinical trial. The results were presented at the recent annual meeting of the International Society for the Advancement of Spine Surgery (ISASS) in Toronto, Canada.

The SCOUT study (Spineology Clinical Outcomes Trial), conducted under an FDA-approved IDE protocol, is a prospective multicenter non-randomized performance goal investigation, designed to evaluate safety and effectiveness outcomes in instrumented lumbar interbody fusion procedures for the treatment of degenerative disc disease (DDD).

The fusion implant used in the SCOUT Study is Spineology’s porous graft containment mesh that deploys within the disc space as it is filled, permitting the packed bone graft to conform to the prepared vertebral body endplates. The system’s design allows for disc space preparation and implant placement through a small cannula.

The SCOUT trial includes 102 patients who were experiencing painful lumbar degenerative disc disease of at least six months’ duration. Patients are skeletally mature adults with single-level symptomatic lumbar DDD requiring interbody fusion. Patients have been enrolled at ten participating study sites. Dr. Chi and his co-authors reported on 84 treated subjects, with 60 completing 6-month follow-up and 29 completing 12-month follow-up. Study enrollment was completed in January of this year.

Statistically significant improvements were seen at both six months and twelve months in scores for low back pain and functional limitations, as recorded by Visual Analog Scale (VAS) and Oswestry Disability Index (ODI) respectively. At 12-month follow-up, all 29 subjects (100%) were fused, as read on CT by two independent radiologists. Twenty-seven of 29 subjects (93%) reported “Excellent” or “Good” satisfaction with their surgery. There were no serious device-related serious adverse events.

“These favorable interim results indicate the Spineology system’s potential to provide good arthrodesis and pain relief while minimizing tissue trauma,” said Dr. Chi. “We have seen shorter operating times, less blood loss, shorter hospital stays and excellent satisfaction for the patients treated in this trial.”

The list of nationwide study sites participating in the SCOUT IDE includes Brigham and Women’s Hospital, University of Vermont, the Spine Institute of Louisiana, Florida Orthopaedic Associates, and Georgetown University, among others. Details of the study may be found at the NIH clinical trials website, https://clinicaltrials.gov/ct2/show/NCT02347410?spons=spineology&rank=1.

Spineology’s OptiMesh^® deployable implant received 510(k) clearance from FDA in 2003 for graft containment within the vertebral body. The SCOUT trial is designed to provide clinical data in support of a regulatory submission to FDA for expanded indications, allowing the company to market the implant to be used with bone graft and supplemental posterior fixation in support of lumbar interbody fusion for treating painful DDD.

“We are grateful to Dr. Chi and all the SCOUT investigators for their dedication in helping us to complete this important clinical trial,” said John Booth, Spineology CEO. “We look forward to completing the patient follow-up and gaining the market clearance that will allow us to market this unique fusion device to spine surgeons and their patients.”

About Spineology Inc.

Spineology Inc. provides innovative, anatomy-conserving spinal technologies for surgeons and their patients. Spineology surgical techniques conserve spinal bone, ligament and muscle tissue. Spineology is committed to increasing procedural efficiency, reducing surgical morbidity and accelerating patient recovery. Learn more at spineology.com.

MEQUON, Wis.–(BUSINESS WIRE)–Titan Spine^®, a medical device surface technology company focused on developing innovative spinal interbody fusion implants, today announced that a review of research supporting its nanoLOCK^® surface technology has been published in the journal SPINE. nanoLOCK^® is the company’s next-generation surface technology featuring enhanced micro and nano-scaled architecture, proven to significantly improve the osteogenic response it creates.¹ It is the only technology with an FDA-nano-clearance and the only technology with a Centers for Medicare & Medicaid Services (CMS) new technology category designation for a nanotechnology surface.

The supplement article, “Spine Implant Surface Technology State of the Art: Separating Fact from Fiction,” authored by Titan Spine^® Chief Medical Officer Paul J. Slosar, M.D., reviews the distinctive differences demonstrated among various types of spinal implant surface technologies, including those developed through additive (coating/3D printing) methods, subtractive methods, and of various materials including polyetheretherketone (PEEK), titanium and combination plasma-sprayed materials.

The review of research shows that the Company’s titanium nanotextured (10^–9m) surface, engineered through a proprietary subtractive process, directly interacts with cells on a molecular level to generate specific cellular responses to drive bone production that porous or micron-scale (10^–6m) implant surfaces cannot. Furthermore, it shows that the combination of the implant material and the nano-scale surface is critical to the ability to stimulate bone formation.

Dr. Slosar commented, “There has been a substantial increase in the promotion of surface-enhanced interbody devices over the past few years, most of which are backed by unsubstantiated marketing claims rather than by science. I felt the time was right to review the previously-published studies that point to one irrefutable fact – the only way to communicate to a patient’s cells in a meaningful way to drive bone growth is to combine titanium and the correct nano-architecture that only Titan Spine’s nanoLOCK^®surface possesses. We are just now starting to produce clinical outcome data to determine if faster patient healing can be tied to the in-vitro findings summarized in this most-recent article. We look forward to publishing the data in the near future.”

The Company will be available to discuss these results at Titan Spine^® Booth #401 during the 2018 International Society for the Advancement of Spine Surgery (ISASS) Annual Meeting, being held April 11 – 13 in Toronto, Canada.

Titan Spine^® offers a full line of Endoskeleton^® titanium implants that feature its proprietary nanoLOCK^® surface technology, which was launched in the U.S. in October 2016 following FDA clearance in late 2014. The nanoLOCK^® surface technology consists of a unique combination of roughened topographies at the macro, micro, and nano levels (MMN™). This unique combination of surface topographies is designed to create an optimal host-bone response and actively participate in the fusion process by promoting the upregulation of osteogenic and angiogenic factors necessary for bone growth, encouraging natural production of bone morphogenetic proteins (BMPs), downregulating inflammatory factors, and creating the potential for a faster and more robust fusion.^2,3,4 All Endoskeleton^® devices are covered by the company’s risk share warranty.

About Titan Spine^®

Titan Spine^®, LLC is a surface technology company focused on the design and manufacture of interbody fusion devices for the spine. The company is committed to advancing the science of surface engineering to enhance the treatment of various pathologies of the spine that require fusion. Titan Spine^®, located in Mequon, Wisconsin and Laichingen, Germany, markets a full line of Endoskeleton^® interbody devices featuring its proprietary textured surface in the U.S., portions of Europe, and Australia through its sales force and a network of independent distributors. To learn more, visit www.titanspine.com.

¹ Olivares-Navarrete, R., Hyzy S.L., Gittens, R.A., Berg, M.E., Schneider, J.M., Hotchkiss, K., Schwartz, Z., Boyan, B. D. Osteoblast lineage cells can discriminate microscale topographic features on titanium-aluminum-vanadium surfaces. Ann Biomed Eng. 2014 Dec; 42 (12): 2551-61.

² Olivares-Navarrete, R., Hyzy, S.L., Slosar, P.J., Schneider, J.M., Schwartz, Z., and Boyan, B.D. (2015). Implant materials generate different peri-implant inflammatory factors: PEEK promotes fibrosis and micro-textured titanium promotes osteogenic factors. Spine, Volume 40, Issue 6, 399–404.

³ Olivares-Navarrete, R., Gittens, R.A., Schneider, J.M., Hyzy, S.L., Haithcock, D.A., Ullrich, P.F., Schwartz, Z., Boyan, B.D. (2012). Osteoblasts exhibit a more differentiated phenotype and increased bone morphogenetic production on titanium alloy substrates than poly-ether-ether-ketone. The Spine Journal, 12, 265-272.

⁴ Olivares-Navarrete, R., Hyzy, S.L., Gittens, R.A., Schneider, J.M., Haithcock, D.A., Ullrich, P.F., Slosar, P. J., Schwartz, Z., Boyan, B.D. (2013). Rough titanium alloys regulate osteoblast production of angiogenic factors. The Spine Journal, 13, 1563-1570.

ALACHUA, Fla.–(BUSINESS WIRE)–RTI Surgical, Inc. (Nasdaq: RTIX), a global surgical implant company, presented data on the SImmetry Sacroiliac Joint Fusion System at the International Society for the Advancement of Spine Surgery (ISASS) 2018 Annual Meeting taking place April 11-13, 2018 in Toronto, Canada. Data show the SImmetry System, the only minimally-invasive surgical procedure that promotes SI joint fusion through decortication, results in significant improvements in pain, disability and opioid use in patients suffering from SI joint dysfunction. RTI is also featuring the Fortilink®-C IBF System, the first in a series of devices to incorporate its TETRAfuse 3D Technology, used as an interbody fusion device in anterior cervical discectomy and fusion (ACDF) surgeries.

“These data add to the growing body of evidence supporting the SImmetry System as an innovative therapy for SI joint pain,” said Camille Farhat, President and CEO, RTI Surgical. “We look forward to sharing these data on the SImmetry System at ISASS, as well as showcasing Fortilink-C with TETRAfuse, our 3D-printed technology with unique features designed to enhance osseointegration and new bone formation.”

SImmetry Data: “Minimally Invasive Sacroiliac Joint Fusion Surgery with Decortication and Threaded Implants: Analysis of the EVoluSIon Clinical Study”

Dr. Ali Araghi from the Core Institute in Phoenix, Arizona, presented six-month clinical outcomes from 100 patients in the ongoing EVoluSIon Clinical Study. The EVoluSIon study is evaluating the impact of the SImmetry System on SI joint fusion and pain reduction in up to 250 patients at up to 40 sites. More than 200 patients have been enrolled to date.

Results showed the SImmetry System provided a 56 percent reduction in patient-reported pain, and a statistically significant reduction in the use of opioids and other pain medications at six months. The study also found a statistically significant improvement in disability and quality of life. These study results add to the growing body of evidence on the effectiveness of the SImmetry System and are consistent with the initial analysis published in December 2017.ⁱ

“We’re pleased to see these results – improvements in pain, disability, and opioid use – are consistent with earlier reported evidence,” Dr. Araghi commented. “We look forward to conducting longer term follow-up to evaluate continued pain reduction, hence an improved quality of life in our patients, as well as associated radiographic fusion rates.”

RTI Features Comprehensive Spine Portfolio at ISASS

RTI will showcase its comprehensive spine portfolio at Booth #412. A key feature will be the Fortilink-C IBF System with TETRAfuse 3D Technology. The Fortilink-C IBF System is the first 3D printed polymer-based, cervical interbody device featuring a nano-roughⁱⁱ surface with antibacterial characteristics^†iii uniquely combined in one radiolucent bone-like material.ⁱⁱ The TETRAfuse 3D Technology is designed to participate in fusion^iv without compromising mechanical integrityⁱⁱ or radiographic visibility,ⁱⁱsuggesting the Fortilink-C IBF System may be an important new option for surgeons commonly using titanium, allograft bone and PEEK systems.

The Fortilink-C IBF System has been available since October 2017. RTI is expanding its Fortilink series featuring TETRAfuse 3D Technology, aiming to launch new offerings later in 2018.

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.

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ⁱ Araghi A et al. Pain and Opioid use Outcomes Following Minimally Invasive Sacroiliac Joint Fusion with Decortication and Bone Grafting: The Evolusion Clinical Trial. Open Orthop J. 2017;11:1440-1448.
ⁱⁱ Data on file at RTI Surgical, Inc.
ⁱⁱⁱ Wang M, Bhardwaj B, Webster T; Antibacterial properties of PEKK for orthopedic applications. Int’l Journal of Nanomedicine. 2017: 12 6471-6476.
^iv Data on file at RTI Surgical, Inc. Performance data from animal studies may not be representative of performance in humans.

^†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.