AUSTIN, Texas–(BUSINESS WIRE)–Ortho Kinematics‚ Inc. (OKI), a privately held healthcare diagnostics company focused on spine imaging informatics, announced today that Erik Wagner has been appointed Interim Chief Executive Officer. Mr. Wagner has been an investor and advisor to OKI for several years.

“The OKI Board of Directors recognized that as the company moves to expand its product offering and market footprint, it needs the experience of a seasoned spine industry executive to usher in the next phase of growth,” said Jerry DeVries, Board Member. “Erik has agreed to help transition the company from a development to a commercial enterprise focused on the launch of the company’s next-generation diagnostic technology.”

Mr. Wagner added, “Ortho Kinematics has the potential to solidify and build on its status as the leader in spine diagnostics. Paul Gunnoe, OKI’s previous CEO, has positioned the company well for success and will be a strategic consultant to the company going forward. We have a tremendous opportunity ahead of us, and I am confident in our ability to accelerate our development and continue to generate value for our shareholders.”

OKI’s core product, the VMA is a diagnostic test for the assessment of spinal motion, instability, and sagittal alignment. Spinal instability and alignment are important considerations for physicians when evaluating candidates for therapies such as surgery and pain management. The VMA has been shown in studies to increase the sensitivity in detecting spinal motion, including instability, with no decrease in specificity relative to the current standard test.

About Erik Wagner

Mr. Wagner has been a co-founder, board member, and held executive management positions in two venture-backed spinal implant companies including Spinal Concepts (1996-2004) and Flexuspine (2007-2014). At Spinal Concepts, he and his partners raised over $40 million in venture capital leading the company to profitability in less than six years on sales exceeding $10 million/month and growing at 70% CAGR. He left Spinal Concepts following the sale of the company to Abbott Labs for $170 million in 2003. His proven record for innovation and leadership continued at Flexuspine where he served as CTO & CEO and led the development and clinical investigation of the world’s first spinal segmental reconstruction device. He is a named inventor on over 80 patents for medical devices ranging from spinal implants to cardiovascular atherectomy devices. He continues to serve as a business consultant and advisor to medical device startups and investor groups.

About Ortho Kinematics

Ortho Kinematics is a privately held diagnostic technology company, focused on spine imaging informatics and committed to the idea that spine motion matters. The company is working with a group of leading clinicians, researchers, and developers who are passionate about leveraging spine biomechanical data to improve the diagnosis and treatment of back pain. Ortho Kinematics is located in Austin, Texas and at www.orthokinematics.com.

ALACHUA, Fla.–(BUSINESS WIRE)–RTI Surgical, Inc. (Nasdaq: RTIX), a global surgical implant company, today announced data on the SImmetry® Sacroiliac Joint Fusion System have been published in The Spine Journal, the official journal of the North American Spine Society. The study results demonstrate the SImmetry System produces effective joint fixation, markedly reducing range of motion (ROM) in the SI joint. The SImmetry System is the only minimally-invasive surgical procedure that uses proprietary decortication technology to help facilitate bone fusion, providing opportunity for long-term relief.

“These results reinforce the effectiveness of the SImmetry System in aiding patients who suffer from chronic low back pain caused by SI joint dysfunction,” said Camille Farhat, President and CEO, RTI Surgical. “The SImmetry System is the only minimally-invasive surgical procedure that promotes SI joint fusion through decortication, reducing the range of motion in all directions with only two implants.”

RTI Surgical recently acquired the SImmetry System as it continues to invest in advanced spinal surgery innovations supported by clinical data, including minimally-invasive technologies that ease the surgical experience and may help patient outcomes.

About The Study: “Biomechanical Evaluation of Sacroiliac Joint Fixation with Decortication”

The manuscript describes the results of a human cadaveric biomechanical study in which two minimally-invasive techniques for placing primary (12.5mm) and secondary (8.5mm) threaded implants were compared for their effectiveness in stabilizing the SI joint. The study also evaluated the link between fixation and bone mineral density, as well as the impact of removing the secondary implant on construct rigidity. Fourteen human cadaveric SI joints were prepared, grafted and then fixated using threaded SImmetry implants. Mechanical testing on the rigidity of the construct and ROM calculation was completed at the study initiation with the joint intact, after destabilization, after implantation, and after removal of the secondary implant.

This biomechanics study found that the SImmetry implants provided a significant, 65-71 percent reduction in joint motion using multiple configurations of the implants. This benefit was maintained after repeated loading, and was greater than that seen in previous studies using triangular SI joint implants. The results provided evidence of immediate fixation, which is intended to relieve pain and provide an environment suited to bone growth across the joint, which is the ultimate goal in long-term relief of SI joint pain.

Growing Body of Evidence on SImmetry System

These study results support the growing body of evidence on the effectiveness of the SImmetry System. The ongoing EVoluSIon Clinical Study is evaluating the impact of SImmetry on SI joint fusion and pain reduction in up to 250 patients at up to 40 sites. More than 180 patients have been enrolled to date. An early analysis of the first 50 patients published in December 2017 showed a 54 percent reduction in SI joint pain at six months as well as a 55 percent reduction in opioid use.¹ A separate CT fusion study on the SImmetry System demonstrated a 73 percent reduction in average pain over 24 months.² Additional data from the EVoluSIon Clinical Study will be presented at the upcoming International Society for the Advancement of Spine Surgery (ISASS) 2018 Annual Meeting taking place April 11-13 in Toronto, Canada.

Approximately 20 percent of all chronic low back pain derives from the SI joint,³ which links the base of the spine to the pelvic bone. When nonsurgical therapy is ineffective in managing SI joint pain, surgical fusion is a viable long-term option. Traditional open fixation is a complex and invasive procedure associated with considerable morbidity and risk of injury.⁴

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, trauma and cardiothoracic 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.

¹ 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.
² Cross W et al. Minimally Invasive Sacroiliac Joint Fusion: 2-Year Radiographic and Clinical Outcomes with a Principles-Based SIJ Fusion System. Open Orthop J. 2018 Jan 17;12:7-16.
³ Cohen SP et al. Sacroiliac Joint Pain: A Comprehensive Review of Epidemiology, Diagnosis and Treatment. Expert Rev Neurother. 2013; 13(1):99-116.
⁴ Snyder LA et al. The technological development of minimally invasive spine surgery. Biomed Res Int. 2014:293582.

MEQUON, Wis.–(BUSINESS WIRE)–Titan Spine, a medical device surface technology company focused on developing innovative spinal interbody fusion implants, today announced it has opened a distribution facility in Memphis to meet the growing demand for the Company’s nanoLOCK® surface technology. 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

The new distribution facility increases Titan Spine’s capacity to more than 20,000 square feet and will be used to efficiently distribute nanoLOCK® as well as products from future launches. In addition, the facility is strategically located within close proximity to the FedEx world distribution hub, which allows Titan Spine to extend shipment hours when needed and enable agility in responding to customer needs.

Mark Berg, Executive Vice President Global Operations of Titan Spine, commented, “As the demand for our nanoLOCK® surface implants has continued to grow across the U.S., we recognized the need to strategically increase our distribution capacity to supply current and future demand. Our Memphis Distribution Center (MDC) offers an optimal solution that builds upon the efforts of our prior distribution partner. We are excited to further improve logistics for our surgeon and distributor customers who recognize the significance and uniqueness of nanoLOCK®’s very specific ability to promote a nano-fusion.”

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.