SAN DIEGO, July 10, 2018 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced the Company will officially unveil its XLIF^® Lordotic Expandable (XLX) Interbody System, which just received 510(k) clearance from the U.S. Food and Drug Administration (FDA), at the 25^th International Meeting on Advanced Spine Techniques (IMAST) in Los Angeles, July 11-14, 2018. NuVasive is a Double Diamond Sponsor of the conference, reflecting its continued support of advancing spine care.

Through controlled lordotic expansion and multifunctional instrumentation, the XLIF anterior column realignment (ACR) technique offers an efficient and minimally disruptive alternative to traditional open procedures. Leveraging the clinical advantages of the XLIF ACR procedure, the XLX ACR system allows the surgeon to address sagittal alignment from the anterior column while reducing blood loss and hospital stays. Scheduled to launch in July 2018, the XLX implant will be offered in a comprehensive range of lengths and heights with up to 30° of customizable lordosis to address varying patient anatomy.

Leveraging Surgical Intelligence™, the Company’s ecosystem for better surgery, XLX ACR has the ability to improve ACR procedures overall. The Integrated Global Alignment (iGA^®) software can calculate alignment parameters with the preoperative planning tools NuvaLine^® and NuvaMap^®, and can intraoperatively evaluate correction using real-time intraoperative assessment with NuvaMap O.R. software. Surgeons can then confirm the restoration and preservation of global sagittal alignment postoperatively.

“The XLX ACR implant adds the first expandable implant to the portfolio of pathology-specific XLIF interbody options,” said Dr. Ivan Cheng, spine surgeon and Associate Professor of Orthopedic Surgery and, by courtesy, Associate Professor of Neurosurgery at Stanford University. “We are now better able to achieve correction of alignment and save patients significant morbidity in comparison with traditional approaches of open posterior spinal fusion with osteotomy—procedures which many of our patients may not tolerate or even survive. XLX ACR provides us the ability to maximize lordosis segmentally and customize the optimal amount of overall lordosis based on patient-specific alignment goals using iGA through a minimally disruptive approach.”

The NuVasive XLX Interbody System is intended for use in the lumbar spine, from L1 to S1, for the treatment of symptomatic disc degeneration or degenerative spondylolisthesis at one or two adjacent levels, including thoracic disc herniation. It can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.

“With the FDA 510(k) clearance of XLX ACR, we broaden our expandable portfolio to the lateral market,” said Matt Link, executive vice president of strategy, technology and corporate development at NuVasive. “This clearance highlights our continued investment in innovation and Lateral Single-Position Surgery to transform clinical outcomes by developing and evolving spine’s leading solutions and systems to give surgeons the tools they need to best serve their patients.”

The XLX ACR implant will join the existing expandable interbody portfolio of  TLX™ and MLX^® as NuVasive’s first lateral expandable. TLX and MLX provide customizable correction with streamlined instrumentation from a TLIF approach.

During IMAST 2018, NuVasive is also showcasing LessRay^® within its spine solutions portfolio, a foundational technology within Surgical Intelligence. LessRay offers the surgeon and hospital system the opportunity to use significantly reduced radiation imaging in the operating room, while providing unique Image Stitching for surgeons to quickly stitch together fluoroscopic images of any spine segment.

NuVasive will be holding two hands-on workshops at this year’s IMAST that tie in with its innovation in Lateral Single-Position Surgery and LessRay.

NuVasive Hands-on Workshops

• Thursday, July 12 from 12:30—1:30 p.m. PST in Diamond Salon 7, JW Marriott L.A. LIVEProtect yourself and your patients with LessRay: A novel technology to reduce radiation and increase OR efficiency. Presented by Stephen I. Ryu, M.D. and Amer Samdani, M.D.
• Friday, July 13 from 12:00—1:00 p.m. PST in Diamond Salon 7, JW Marriott L.A. LIVELeading. Expanding. Advancing. Insights to Lateral Procedural Solutions. Presented by Christopher R. Brown, M.D. and Jeff Lehmen, M.D.

IMAST 2018 attendees are encouraged to stop by NuVasive booth #32 to learn more about XLX ACR, LessRay and the Company’s comprehensive, industry-leading solutions for creating better clinical outcomes for spine procedures.

About NuVasive

NuVasive, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, focused on transforming spine surgery and beyond with minimally disruptive, procedurally-integrated solutions designed to deliver reproducible and clinically-proven surgical outcomes. The Company’s portfolio includes access instruments, implantable hardware, biologics, software systems for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative monitoring service offerings. With over $1 billion in revenues, NuVasive has an approximate 2,400 person workforce in more than 40 countries serving surgeons, hospitals and patients. For more information, please visit www.nuvasive.com.

Forward-Looking Statements

NuVasive cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause NuVasive’s results to differ materially from historical results or those expressed or implied by such forward-looking statements. The potential risks and uncertainties which contribute to the uncertain nature of these statements include, among others, risks associated with acceptance of the Company’s surgical products and procedures by spine surgeons, development and acceptance of new products or product enhancements, clinical and statistical verification of the benefits achieved via the use of NuVasive’s products (including the iGA platform), the Company’s ability to effectually manage inventory as it continues to release new products, its ability to recruit and retain management and key personnel, and the other risks and uncertainties described in NuVasive’s news releases and periodic filings with the Securities and Exchange Commission. NuVasive’s public filings with the Securities and Exchange Commission are available at www.sec.gov. NuVasive assumes no obligation to update any forward-looking statement to reflect events or circumstances arising after the date on which it was made.

SOURCE NuVasive, Inc.

Related Links

http://www.nuvasive.com

July 10, 2018

BELGRADE, MT, July 10, 2018 (GLOBE NEWSWIRE) — Xtant Medical Holdings, Inc. (NYSE American:XTNT), a leader in the development of regenerative medicine products and medical devices, today announced the appointment of Kevin Brandt to the new executive position of Chief Commercial Officer effective July 9, 2018.

“We are excited to have such a talented and experienced executive officer join our team,” said Carl O’Connell, chief executive officer of Xtant. “Kevin’s past accomplishments in the medical device industry show that he is an accomplished business strategist with a unique ability to provide the leadership in sales and marketing to build our Company’s revenues and profitability. I expect his contributions will be transformative for Xtant.”

Brandt brings to Xtant more than 28 years of experience in the medical device industry. As the former executive vice president and chief commercial officer of RTI Surgical, Inc.’s domestic direct business, Brandt led all domestic direct lines of business and R&D for a global surgical implant company marketing biologic, medical and synthetic implants. Prior to joining RTI Surgical in 2012, Brandt spent 18 years at Stryker Corporation from 1994-2012 in various senior commercial leadership positions. Most notably, while at Stryker he served as President of Osteokinetics from 2002-2012 as one of their largest distributors and prior to that he was Senior Director of US Spine sales from 2000-2001 responsible for creating and leading Stryker’s US Spine sales organization.

“I’m thrilled to be joining the Xtant team to lead the development and execution of their commercial strategy”, indicated Kevin Brandt. “Xtant’s legacy portfolio of biologics and fixation products provide a great foundation to build upon in the field of regenerative medicine and medical devices”.

About Xtant Medical

Xtant Medical develops, manufactures and markets regenerative medicine products and medical devices for domestic and international markets. Xtant Medical products serve the specialized needs of orthopedic and neurological surgeons, including orthobiologics for the promotion of bone healing, implants and instrumentation for the treatment of spinal disease, tissue grafts for the treatment of orthopedic disorders, and biologics to promote healing following cranial, and foot and ankle surgeries. With core competencies in both biologic and non-biologic surgical technologies, Xtant Medical can leverage its resources to successfully compete in global neurological and orthopedic surgery markets. For further information, please visit www.xtantmedical.com.

Important Cautions Regarding Forward-looking Statements

This press release contains certain disclosures that may be deemed forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements that are predictive in nature, that depend upon or refer to future events or conditions, or that include words such as ‘‘continue,’’ ‘‘expects,’’ ‘‘anticipates,’’ ‘‘intends,’’ ‘‘plans,’’ ‘‘believes,’’ ‘‘estimates,’’ ‘‘strategy,’’ ‘‘will,’’ “can” or similar expressions or the negative thereof. Statements of historical fact also may be deemed to be forward-looking statements. The Company cautions that these statements by their nature involve risks and uncertainties, and actual results may differ materially depending on a variety of important factors, including, among others: the ability to increase revenue; the ability to achieve expected results; the ability to remain competitive; the ability to innovate and develop new products; the ability to engage and retain qualified personnel; government and third-party coverage and reimbursement for Company products; the ability to obtain and maintain regulatory approvals; government regulations; product liability claims and other litigation to which we may be subjected; product recalls and defects; timing and results of clinical studies; the ability to obtain and protect Company intellectual property and proprietary rights and operate without infringing the rights of others; the ability to service Company debt and comply with debt covenants; the ability to raise additional financing and other factors. Additional risk factors are listed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2017 filed with the Securities and Exchange Commission (SEC) on April 2, 2018 and subsequent SEC filings by the Company, including without limitation its Quarterly Report on Form 10-Q for the quarter ended March 31, 2018. Investors are encouraged to read the Company’s filings with the SEC, available at www.sec.gov, for a discussion of these and other risks and uncertainties. The Company undertakes no obligation to release publicly any revisions to any forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, except as required by law. All forward-looking statements attributable to us or persons acting on our behalf are expressly qualified in their entirety by this cautionary statement.

Contact:
Xtant Medical Holdings, Inc.
Molly Mason
mmason@xtantmedical.com

LEESBURG, Va., July 10, 2018 (GLOBE NEWSWIRE) — K2M Group Holdings, Inc. (NASDAQ:KTWO) (the “Company” or “K2M”), a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance^™, today announced it will showcase its 3D spinal balance portfolio and Balance ACS^® Platform at the 25^th International Meeting on Advanced Spine Techniques (IMAST) in Los Angeles, CA, at Booth #29. Additionally, the Company will host four interactive workshops facilitated by distinguished leaders in spine surgery.

“K2M is excited to attend this year’s IMAST, a prestigious meeting for surgeons to explore the latest topics, technologies, and techniques in spinal deformity,” said John P. Kostuik, MD, Chief Medical Officer and Co-founder at K2M. “Over the past year, we have grown our product offering—as evidenced by our 100^th product milestone and our launch of BACS Patient-Specific Rods & Rails at IMAST. We remain committed each day to inventing new solutions that help surgeons improve the lives of people living with spinal disease.”

At the meeting, K2M will showcase its comprehensive 3D spinal balance portfolio. Products include the YUKON^™ OCT Spinal System, NILE^® Alternative Fixation Spinal System, RAVINE^® Lateral Access System, EVEREST^® MI and MI XT Spinal Systems, CHESAPEAKE^® Anterior-Lumbar Stabilization System, OZARK^™ Cervical Plate Systems, and more.

The Company will also feature Balance ACS (BACS^®), which provides solutions to help surgeons achieve balance of the spine by addressing each anatomical vertebral segment with a 360-degree approach to the axial, coronal, and sagittal planes, emphasizing Total Body Balance as an important component of surgical success.

K2M to Host Interactive Workshops in Diamond Salon 6

• Techniques for Correcting Cervical Spine Deformities
  Wednesday, July 11 (4:00–6:00 p.m.)
  Christopher Ames, MD; Steven Glassman, MD; Jeffrey Gum, MD

• Using Spinopelvic Parameters to Optimize Correction in the Adult Patient
  Thursday, July 12 (12:30–1:30 p.m.)
  Christopher Ames, MD; Shay Bess, MD; Robert Lee, BSc, FRCS

• Alternative Fixation Using Band Technology
  Thursday, July 12 (5:15–6:15 p.m.)
  Gregory Mundis, MD; Burt Yaszay, MD

• Hybrid Approaches to Deformity Surgery
  Friday, July 13 (12:00–1:00 p.m.)
  Robert Lee, BSc, FRCS

For more information on K2M’s complete product portfolio, visit www.K2M.com. For more information on Balance ACS, visit www.BACS.com.

About K2M Group Holdings, Inc.

K2M Group Holdings, Inc. is a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance. Since its inception, K2M has designed, developed, and commercialized innovative complex spine and minimally invasive spine technologies and techniques used by spine surgeons to treat some of the most complicated spinal pathologies. K2M has leveraged these core competencies into Balance ACS, a platform of products, services, and research to help surgeons achieve three-dimensional spinal balance across the axial, coronal, and sagittal planes, with the goal of supporting the full continuum of care to facilitate quality patient outcomes. The Balance ACS platform, in combination with the Company’s technologies, techniques and leadership in the 3D-printing of spinal devices, enable K2M to compete favorably in the global spinal surgery market. For more information, visit www.K2M.com and connect with us on Facebook, Twitter, Instagram, LinkedIn and YouTube.

Forward-Looking Statements

This press release contains forward-looking statements that reflect current views with respect to, among other things, operations and financial performance.  Forward-looking statements include all statements that are not historical facts such as our statements about our expected financial results and guidance and our expectations for future business prospects.  In some cases, you can identify these forward-looking statements by the use of words such as, “outlook,” “guidance,” “believes,” “expects,” “potential,” “continues,” “may,” “will,” “should,” “could,” “seeks,” “predicts,” “intends,” “plans,” “estimates,” “anticipates” or the negative version of these words or other comparable words.

Such forward-looking statements are subject to various risks and uncertainties including, among other things: our ability to achieve or sustain profitability in the future; our ability to demonstrate to spine surgeons and hospital customers the merits of our products and to retain their use of our products; pricing pressures and our ability to compete effectively generally; collaboration and consolidation in hospital purchasing; inadequate coverage and reimbursement for our products from third-party payers; lack of long-term clinical data supporting the safety and efficacy of our products; dependence on a limited number of third-party suppliers; our ability to maintain and expand our network of direct sales employees, independent sales agencies and international distributors and their level of sales or distribution activity with respect to our products; proliferation of physician-owned distributorships in the industry; decline in the sale of certain key products; loss of key personnel; our ability to enhance our product offerings through research and development; our ability to maintain adequate working relationships with healthcare professionals; our ability to manage expected growth; our ability to successfully acquire or invest in new or complementary businesses, products or technologies; our ability to educate surgeons on the safe and appropriate use of our products; costs associated with high levels of inventory; impairment of our goodwill and intangible assets; disruptions to our corporate headquarters and operations facilities or critical information technology systems or those of our suppliers, distributors or surgeon users; our ability to ship a sufficient number of our products to meet demand; our ability to strengthen our brand; fluctuations in insurance cost and availability; our ability to remediate the material weaknesses in our IT general controls; our ability to comply with extensive governmental regulation within the United States and foreign jurisdictions; our ability to maintain or obtain regulatory approvals and clearances within the United States and foreign jurisdictions; voluntary corrective actions by us or our distribution or other business partners or agency enforcement actions; recalls or serious safety issues with our products; enforcement actions by regulatory agencies for improper marketing or promotion; misuse or off-label use of our products; delays or failures in clinical trials and results of clinical trials; legal restrictions on our procurement, use, processing, manufacturing or distribution of allograft bone tissue; negative publicity concerning methods of tissue recovery and screening of donor tissue; costs and liabilities relating to environmental laws and regulations; our failure or the failure of our agents to comply with fraud and abuse laws; U.S. legislative or Food and Drug Administration regulatory reforms; adverse effects associated with the exit of the United Kingdom from the European Union; adverse effects of medical device tax provisions; potential tax changes in jurisdictions in which we conduct business; our ability to generate significant sales; potential fluctuations in sales volumes and our results of operations over the course of a fiscal year; uncertainty in future capital needs and availability of capital to meet our needs; our level of indebtedness and the availability of borrowings under our credit facility; restrictive covenants and the impact of other provisions in the indenture governing our convertible senior notes and our credit facility; worldwide economic instability; our ability to protect our intellectual property rights; patent litigation and product liability lawsuits; damages relating to trade secrets or non-competition or non-solicitation agreements; risks associated with operating internationally; fluctuations in foreign currency exchange rates; our ability to comply with the Foreign Corrupt Practices Act and similar laws; increased costs and additional regulations and requirements as a result of being a public company; our ability to implement and maintain effective internal control over financial reporting; potential volatility in our stock price; our lack of current plans to pay cash dividends; potential dilution by the future issuances of additional common stock in connection with our incentive plans, acquisitions or otherwise; anti-takeover provisions in our organizational documents and our ability to issue preferred stock without shareholder approval; potential limits on our ability to use our net operating loss carryforwards; and other risks and uncertainties, including those described under the section entitled “Risk Factors” in our most recent Annual Report on Form 10-K filed with the SEC, as such factors may be updated from time to time in our periodic filings with the SEC, which are accessible on the SEC’s website at www.sec.gov.  Accordingly, there are or will be important factors that could cause actual outcomes or results to differ materially from those indicated in these statements.  These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in this release and our filings with the SEC.

We operate in a very competitive and challenging environment. New risks and uncertainties emerge from time to time, and it is not possible for us to predict all risks and uncertainties that could have an impact on the forward-looking statements contained in this release. We cannot assure you that the results, events and circumstances reflected in the forward-looking statements will be achieved or occur, and actual results, events or circumstances could differ materially from those described in the forward-looking statements.

The forward-looking statements made in this press release relate only to events as of the date on which the statements are made. We undertake no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as required by law. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements and you should not place undue reliance on our forward-looking statements. Unless specifically stated otherwise, our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures, investments or other strategic transactions we may make.

Media Contact:

Zeno Group on behalf of K2M Group Holdings, Inc.
Christian Emering, 212-299-8985
Christian.Emering@ZenoGroup.com

Investor Contact:

Westwicke Partners on behalf of K2M Group Holdings, Inc.
Mike Piccinino, CFA, 443-213-0500
K2M@westwicke.com

MINNEAPOLIS, July 10, 2018 (GLOBE NEWSWIRE) — Relievant Medsystems, a privately-held medical device company developing minimally-invasive solutions for chronic low back pain (CLBP), announced today the successful completion of the first commercial Intracept Procedures.  The procedures were performed by Dr. Bradly Goodman at OrthoAlabama Spine & Sports in Birmingham, Alabama and Dr. Erik Bendiks at Georgia Spine & Orthopaedics in Atlanta, Georgia.

Chronic low back pain is a widespread and often severely debilitating condition that is estimated to affect nearly 30 million people in the US, costing nearly $150 billion each year in medical treatment and lost productivity. Patients suffering from CLBP typically initiate treatment with conservative therapies such as activity modification, medications, bracing, physical therapy, manipulation and steroid injections. Existing therapies fail to provide adequate pain relief for approximately 80 percent of CLBP patients.

The Intracept Procedure is based on groundbreaking research that identified and demonstrated the role of the basivertebral nerve in transmitting low back pain. The procedure utilizes a minimally invasive approach to reach the basivertebral nerve near the center of the vertebral body and delivers radiofrequency energy to ablate the nerve; once ablated, these nerves no longer transmit pain signals. Spine surgeons and interventional pain specialists perform the Intracept Procedure under image guidance in the outpatient setting, with the entire procedure taking 60-90 minutes. Treated patients report nearly immediate relief of their back pain.

The company published the results of the SMART trial, a Level I, sham-controlled randomized controlled trial (RCT) in February 2018 and is currently enrolling patients in a second Level I RCT, the INTRACEPT study, at 20 US sites to expand the portfolio of evidence demonstrating the benefits of the Intracept Procedure.

“We are pleased to initiate the commercialization of Intracept in the United States and to offer this clinically-proven pain relief option to the large segment of chronic low back pain patients who cannot find relief from conservative care and who are not surgical candidates,” said Kevin Hykes, President and Chief Executive Officer. “The ability to intervene early in the disease continuum with this minimally invasive treatment has the potential to significantly improve quality of life and to reduce or eliminate the need for opioids. We are committed to working with patients, physicians and payors to facilitate access to this important new therapy.”

About the INTRACEPT Clinical Study
Relievant is sponsoring the INTRACEPT clinical study to compare outcomes in CLBP patients treated with the Intracept Procedure versus standard medical care. The primary efficacy endpoint is the mean change from baseline to 3 months post-treatment in the ODI, a measurement of the impact of back pain on functional status. The Intracept Procedure will also be evaluated for impact in reducing healthcare costs. The INTRACEPT study will enroll up to 150 patients at up to 20 leading medical centers across the U.S. Patients will be randomized 1:1 between the Intracept Procedure arm vs non-surgical management therapies to treat their CLBP.  Patients in the control arm will have the opportunity to receive the Intracept Procedure after 12 months.  Please visit www.intraceptstudy.com for more information.

About Relievant Medsystems
Founded in 2006 and with offices in Minneapolis, MN, and Sunnyvale, CA, Relievant Medsystems is a privately held medical device company developing new solutions to improve the quality of life for millions of patients suffering from CLBP.

FDA has cleared Relievant’s Intracept System for the following Indications for Use: The Intracept Intraosseous Nerve Ablation System is intended to be used in conjunction with radiofrequency (RF) generators for the ablation of basivertebral nerves of the L3 through S1 vertebrae for the relief of chronic low back pain of at least 6 months duration that has not responded to at least six months of conservative care and is also accompanied by either Type 1 or Type 2 Modic changes on an MRI.

As with any surgical procedure, there are risks and considerations associated with the Intracept Procedure.  Please visit www.relievant.com for a discussion of the risks, contraindications, warnings, precautions and a summary of the pivotal clinical trial data on the device.

Contact
Chris Geyen
Chief Financial Officer
(650) 368-1000
investors@relievant.com

July 09, 2018

SAN DIEGO, July 9, 2018 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced that the first peer-reviewed publication from the NuVasive-sponsored multicenter Integrated Global Alignment (iGA^®) study is now available in the journal Spine. This initial study evaluated the preoperative prevalence and incidence of postoperative spinopelvic malalignment in patients who underwent one- or two-level lumbar fusions for degenerative (non-deformity) indications.

Spinopelvic malalignment (i.e., Pelvic Incidence (PI) minus Lumbar Lordosis (LL) greater than or equal to 10°) following lumbar fusion has been shown to be associated with lower postoperative health-related quality of life and elevated risk of adjacent segment failure; however, the incidence of this in short-segment degenerative lumbar fusions from a large sample of patients had been previously unreported.¹

The article, “A multicenter radiographic evaluation of the rates of preoperative and postoperative malalignment in degenerative spinal fusions,” reports on the rates of malalignment in nearly 600 patients whose measurements were retrospectively acquired. Researchers measured lateral preoperative and postoperative lumbar radiographs of one- or two-level lumbar fusion patients using the NuVasive iGA platform. The study was conducted at 18 institutions with 24 treating investigators in the United States. Patients were grouped as either aligned (PI-LL<10°) or malaligned (PI-LL≥10°) both pre- and postoperatively.

The results show malalignment is common both before and after short-segment degenerative fusions. Preoperatively, 173 (30 percent) patients undergoing one- or two-level lumbar fusion surgery for degenerative conditions exhibited malalignment and postoperatively, 161 (28 percent) patients were malaligned. These relatively high rates of pre- and postoperative malalignment, even in degenerative cases, demonstrate this is not a deformity-only problem and alignment should be measured in all cases.

“This study further demonstrates that incorporating alignment measurements using iGA into our surgical planning directly translates to our patients and the clinical benefits/outcomes we know are influenced by achieving global spinal alignment,” said Jean-Christophe Leveque, M.D., from the Neuroscience Institute, Virginia Mason Hospital and Medical Center in Seattle. “Alignment in deformity procedures has been relevant for years, but this is the first multicenter study to show just how common malalignment is both before and after short-segment, degenerative fusions. We need to shift our mindset as spine surgeons, recognize these results from simple degenerative cases and start measuring spinopelvic parameters in all of our lumbar fusion cases, especially those that involve L4 through S1.”

The conclusion of the study was that alignment preservation and restoration considerations should be incorporated into the decision-making of all lumbar spinal fusions. Prior to this research, spinal alignment considerations were only thought necessary for spinal deformity cases.

The published results of this study and two additional iGA studies evaluating 1) changes between preoperative standing and intraoperative recumbent alignment and 2) the role of pre- and intraoperative alignment planning on surgical execution and outcomes, will be on the podium at the North American Spine Society (NASS) Annual Meeting in September.

“NuVasive has been focused on the importance of alignment and the impact it has on achieving surgical goals and enhanced clinical outcomes well before we launched iGA in 2015,” said Matt Link, executive vice president, strategy, technology, and corporate development. “We have partnered with some of the largest academic institutions in the country to lead the research efforts and build the scientific evidence to advance the understanding of spinal alignment and the importance it plays in surgical decision-making—further transforming spine and how surgeons approach treatment. These studies are helping drive the future of iGA and adding further value and credibility to our systems-based spine solutions.”

Integrated Global Alignment—Why Alignment Matters™

NuVasive is committed to a global approach for assessing, preserving, and restoring spinal alignment in an effort to promote surgical efficiencies, lasting patient outcomes, and improved quality of life. Integration across the surgical workflow allows the surgeon to confidently and reproducibly calculate, correct and confirm optimal spinal alignment.

To learn more about the NuVasive Integrated Global Alignment platform, visit https://www.nuvasive.com/solutions/iga-integrated-global-alignment/.

About NuVasive

NuVasive, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, focused on transforming spine surgery and beyond with minimally disruptive, procedurally-integrated solutions designed to deliver reproducible and clinically-proven surgical outcomes. The Company’s portfolio includes access instruments, implantable hardware, biologics, software systems for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative monitoring service offerings. With over $1 billion in revenues, NuVasive has an approximate 2,400 person workforce in more than 40 countries serving surgeons, hospitals and patients. For more information, please visit www.nuvasive.com.

Forward-Looking Statements

NuVasive cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause NuVasive’s results to differ materially from historical results or those expressed or implied by such forward-looking statements. The potential risks and uncertainties which contribute to the uncertain nature of these statements include, among others, risks associated with acceptance of the Company’s surgical products and procedures by spine surgeons, development and acceptance of new products or product enhancements, clinical and statistical verification of the benefits achieved via the use of NuVasive’s products (including the iGA platform), the Company’s ability to effectually manage inventory as it continues to release new products, its ability to recruit and retain management and key personnel, and the other risks and uncertainties described in NuVasive’s news releases and periodic filings with the Securities and Exchange Commission. NuVasive’s public filings with the Securities and Exchange Commission are available at www.sec.gov. NuVasive assumes no obligation to update any forward-looking statement to reflect events or circumstances arising after the date on which it was made.

¹Leveque JA, Segebarth B, Schroerlucke SR, et al. A multicenter radiographic evaluation of the rates of preoperative and postoperative malalignment in degenerative spinal fusions. Spine 2018;43(13):E782-89.

SOURCE NuVasive, Inc.

Related Links

http://www.nuvasive.com

SAN DIEGO (PRWEB) JULY 03, 2018

SpineMark is the premier global spine service company for the development of Spine Destination Centers and Spine Research Organizations. Through partnerships with hospitals and physicians nationwide and globally, the company develops and operates comprehensive, evidence-based spine centers of excellence to improve the overall quality of life of patients afflicted with spine disorders and injuries. SpineMark is pleased to announce a partnership with Regenexx to provide an innovative, minimally invasive surgical alternative for many common spine conditions. Regenexx will likewise be referring candidates for surgery to SpineMark centers for excellence.

Regenexx provides non-surgical alternatives to treat orthopedic injuries and arthritis, and a broad range of neck and spine conditions such as degenerative disk disease, bulging disks. Founding the field of Interventional Orthopedics, Regenexx cell-based procedures effectively intervene on 70% of orthopedic injuries and conditions where surgery was previously the only solution. This approach enables self-insured employers to save more than 80% on orthopedic costs, all while providing best-in-class outcomes. The Regenexx process of treating musculoskeletal conditions involves a level of physician skill and patented protocols to customize cell based treatments which can only be achieved through Regenexx standards of practice.

“The time is right for the mutual synergies of Regenexx and SpineMark to unite,” said Marcy Rogers, President of SpineMark. “Both companies are privileged to work with the greatest physician leaders in the industry in providing innovative solutions to patients and medical tourists suffering from musculoskeletal and spinal conditions as well as employers, third-party payors and lawyers. We believe this agreement will help support the paradigm shift of services Regenexx and SpineMark offer in their respective fields of interventional orthopedics and minimally invasive spine surgery in the U.S. and abroad.”

“The Regenexx Interventional Orthopedic strategy offers a unique solution for employers to realize immediate savings day-one, dollar one while providing an alternative that employees have chosen over 99% in lieu of surgery,” said Jason Hellickson, CEO of Regenexx. Regenexx clinics are the only regenerative medicine solution with the capability to serve a nationwide footprint with the same standard of care from coast to coast with 60 clinic locations across the country and an additional 70 locations projected by the end of 2019.

About SpineMark 
SpineMark Corporation is a service organization dedicated to transforming the delivery of care for spinal injuries. The company partners with hospitals and physicians across the United States and globally to develop and operate comprehensive, evidence-based spine centers of excellence. By building a global network of spine centers, spine research organizations and state-of-the-art medical conference facilities, SpineMark is improving the overall quality of life of patients afflicted with spine disorders and injuries.

Driven by the specialized experience and expertise of its leadership team and Medical Advisory Board, SpineMark maintains high standards for spine care in its global network, creating clinically validated best practices for spine care that streamline diagnosis and treatment, simplify referrals and accelerate the recovery process.

About Regenexx 
Regenexx is a nationwide network of physicians who practice Interventional Orthopedics, a new specialty that focuses on using the most advanced regenerative-medicine protocols available as an alternative to many orthopedic surgeries. Regenexx has published roughly half of the research world-wide on the use of stem cells for treating orthopedic injuries, and our patented treatment lab-processing and treatment protocols allow us to achieve unmatched results. Regenexx procedures use your body’s natural healing agents including blood platelets and stem cells to repair damaged bone, muscle, cartilage, tendons, and ligaments. We believe in educating patients, offering options, and encouraging people to take an active role in their own treatment.

For more information on Regenexx Corporate visit http://www.regenexxcorporate.com or call 888-547-6667.
For more information on the Regenexx procedures visit http://www.regenexx.com.