Company Introduces First of Its Kind Technology for Intraoperative Reconciliation to Ensure Optimal Alignment in Spine Surgery
SAN DIEGO, CA – May 4, 2015 – NuVasive, Inc. (NASDAQ: NUVA) ("NuVasive or the "Company"), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally integrated solutions, today announced the launch of its Integrated Global Alignment (iGA) platform. The Company believes this new platform marks a significant advancement in the historical approach to spine surgery by integrating procedural technology and tools into one platform to help address proper alignment. The announcement was made at the 83rd American Association of Neurological Surgeon (AANS) Annual Meeting, held May 2-6, 2015, in Washington, D.C.
"More than a decade ago, NuVasive redefined minimally disruptive spine surgery with the introduction of our revolutionary XLIF® technology; the first procedure of its kind designed to safely and reproducibly enable a lateral approach to spine surgery," said Pat Miles, President and Chief Operating Officer of NuVasive. "Today, with the launch of iGA, NuVasive is once again positioned to reshape the market through game-changing innovation and address the next frontier in spine surgery – ALIGNMENT. Proper alignment is the most correlative element of successful, long-term surgical outcomes. With new tools and technology available to us today, NuVasive is taking our 'know-how' to the next level to help drive better patient outcomes in spine surgery through the global alignment of the spine with the only integrated surgical platform that allows for intraoperative reconciliation to ensure global alignment is achieved."
The importance of global alignment in achieving superior clinical outcomes is highlighted in a review published in the Journal of Neurosurgery: Spine[i], which found that the achievement of postoperative alignment resulted in higher long-term success in patient outcomes. Despite this growing body of evidence, the majority of surgeons do not take preoperative measurement of alignment parameters. However, among those surgeons that do, they do not currently have the means to intraoperatively reconcile to desired alignment corrections, leaving most surgeons to focus only on decompression and stabilization elements of procedures.
Dr. Regis Haid, Neurosurgeon at Atlanta Brain and Spine Care, said, "There is a growing consensus from academic and surgical communities that pelvic alignment has a profound impact on patient outcomes. Over the years, we have seen incremental improvements in various spine surgical tools, such as pedicle screws, pre-contoured rods and interbody implants, but the factor that has driven the greatest improvement in our understanding of patient outcomes is our realization of the crucial role that our ability to reestablish alignment plays in both early and long-term patient success."
The iGA Platform
iGA is a proprietary, procedurally integrated, digital platform of specialized products designed to help surgeons achieve more precise spinal column alignment. The platform prioritizes the importance of proper alignment and its potential to impact positive patient outcomes. The iGA platform includes a collection of products, including next generation posterior fixation, anterior and posterior implants, updated neuromonitoring and computer-assisted surgical planning technology. The suite of proprietary, procedurally-based technologies that comprise iGA are designed to enhance clinical outcomes by increasing the predictability of achieving global alignment in spinal procedures.
Newly launched products in the iGA platform include ReLine™, NuvaMap™, Nuvaline™, NuvaMap O.R. and Bendini®. These products, which are seamlessly integrated across the surgical workflow, are designed to help the surgeon:
- CALCULATE alignment parameters with NuvaMap and Nuvaline preoperative planning tools;
- CORRECT the anterior and posterior columns with comprehensive implant solutions using real-time intraoperative assessment via NuvaMap O.R.; and
- CONFIRM the restoration and preservation of global sagittal alignment postoperatively, again through NuvaMap and Nuvaline.
"Spine surgeons are becoming increasingly cognizant of the importance of preoperative measurements in sagittal balance and subsequent alignment correction. However, until now, we did not have the tools to confirm these measurements while the patient is still in surgery," added Dr. Haid. "iGA is the first platform offering that is capable of confirming alignment and measuring correction intraoperatively. I believe this technology has the potential to substantially improve patient outcomes. We are only just beginning to use the technology and early experience has been extremely promising."
Surgical Platform Launch and Live Demonstrations (AANS Booth #1031)
NuVasive's new surgical platform will officially launch at the Company's exhibition booth (#1031) at the AANS Annual Meeting, beginning May 4, 2015, at 9:00 a.m. EDT. The innovations to be showcased include the Company's enhanced Bendini spinal rod bending system, ReLine comprehensive posterior fixation system, NuvaMap, Nuvaline and NuvaMap O.R. surgical planning software integrated with new procedures, including ALIF ACR®, XLIF ACR® and cervical ACR to help correct sagittal alignment. NuVasive's AANS exhibit will also feature the Company's industry-leading MAS® TLIF, MAS PLIF, XLIF and ALIF products, along with its comprehensive cervical portfolio, NVM5® neuromonitoring system, and the other products and procedural innovations that have enabled NuVasive to become the third largest player in the $9 billion global spine market.
NuVasive is an innovative global medical device company that is changing spine surgery with minimally disruptive surgical products and procedurally integrated solutions for the spine. The Company is the third largest player in the $9 billion global spine market. NuVasiveoffers a comprehensive spine portfolio of more than 90 unique products developed to improve spine surgery and patient outcomes. The Company's principal procedural solution is its Maximum Access Surgery, or MAS, platform for lateral spine fusion. MAS was designed to provide safe, reproducible, and clinically proven outcomes, and is a highly differentiated solution with fully integrated neuromonitoring, customizable exposure and a broad offering of application-specific implants and fixation devices designed to address a variety of pathologies.
About Integrated Global Alignment ( iGA)
Integrated Global Alignment (iGA) is a proprietary, procedurally integrated digital platform enabling precise spinal column alignment. The multi-product suite of spine surgical devices forms a complete procedural platform and operating philosophy that centers on the critical importance of proper alignment. The launch of the iGA platform includes a suite of alignment focused offerings, such as the introduction of next generation fixation, anterior and posterior implants, updated neuromonitoring and computer-assisted rod bending and surgical planning technology. It is this combination of procedurally-based technologies that are unique to NuVasive and designed to enhance clinical outcomes by increasing the predictability of achieving global alignment in spinal procedures.
NuVasive cautions you that statements included in this news release or made during the 2015 AANS Annual Meeting 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 that 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, expansion of its network of sales representatives, clinical and statistical verification of the benefits achieved via the use of NuVasive's products (including the iGA platform), and the other risks and uncertainties more fully 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.