NuVasive Announces Regulatory Approval Of Reline® Posterior Fixation Technology In Japan

Largest and Fastest Growing International Market Readies for Introduction of iGA™ Platform to Address Spinal Alignment and Drive Improved Long-Term Patient Outcomes

SAN DIEGO, CA – March 9, 2016 – NuVasive, Inc. (NASDAQ: NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, announced today that it has received regulatory Shonin approval for its Reline posterior fixation technology in Japan.  This approval now sets the stage for the launch of the Company’s game-changing Integrated Global Alignment (iGA) platform in Japan.

Jason M. Hannon, Executive Vice President, International, said, “We are very pleased to receive regulatory approval of Reline in Japan as it moves us toward launching our industry-leading iGA technology in our largest and fastest growing international market.  Japan’s exceptional growth over the last three years demonstrates the clear benefit of focusing our market penetration efforts around our complete procedural offerings such as XLIF®, which we are now replicating in additional key international markets.”

“With the pending launch of iGA in Japan, we expect to drive robust adoption of this technology to address proper spinal alignment and drive improved long-term patient outcomes.  In doing so, we aim to mirror the positive impact iGA has already had in driving our strong lumbar momentum in the U.S. over the past several quarters.  The continued success of our Precept® posterior fixation system, augmented now by the approval of Reline, supports our confidence in fueling more than 30% growth in our Japanese market for the year as we look to approach the $40 million revenue mark for 2016 – a key contributor to our core NuVasive international growth of approximately 20% this year,” Mr. Hannon concluded.

Japan is the world’s second largest spine market and NuVasive’s largest market outside of the U.S.  The Company first entered the Japanese market in 2013 leading with the highly differentiated benefits of its minimally invasive XLIF surgical approach.  More than three years later, NuVasive has trained hundreds of surgeons on the XLIF technology and thousands of patients have been treated with the NuVasive’s comprehensive portfolio of procedurally integrated solutions for the spine, providing reproducible and clinically proven surgical outcomes.

Reline Posterior Fixation Technology

The Reline portfolio is the evolution of posterior fixation technology within the iGA platform that can be utilized in open surgeries or with the Company’s Maximum Access Surgery, or MAS®, procedural solutions.  The Reline launch will begin later this year in Japan and continue into 2017.

Whether preserving or restoring spinal alignment, the seamless and versatile design of Reline provides one system to address even the most difficult pathologies for both deformity and degenerative applications.  The competitive benefits of Reline include surgical efficiency, operative reliability and procedural versatility.  Its Universal Open and MAS solutions were created to help deliver an enhanced surgical experience with fully compatible Open and MAS instrumentation, seamless integration with the Company’s NVM5® neuromonitoring technology, and streamlined rod insertion facilitated by the Bendini® Rod Bending system.

The iGA Advantage

NuVasive believes iGA is an industry-leading platform that 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 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.  The iGA platform is seamlessly integrated across the surgical workflow and is designed to help the surgeon:

  • CALCULATE alignment parameters with preoperative planning tools;
  • CORRECT the anterior and posterior columns with comprehensive implant solutions using real-time intraoperative assessment; and
  • CONFIRM the restoration and preservation of global sagittal alignment postoperatively.

About NuVasive

NuVasive is an innovative global medical device company that is transforming spine surgery with minimally disruptive surgical products and procedurally-integrated solutions for the spine.  NuVasive has emerged from a small startup to become the #3 player in the $9 billion global spine market and remains focused on market share-taking strategies as the Company continues on its path to become the industry’s leading spine company.  NuVasive offers 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.

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.  Forward-looking statements include, but are not limited to, statements about the timing of the launch of Reline and the iGA™ platform in Japan, as well as the anticipated benefits and expectations for growth and financial performance in 2016. The forward-looking statements contained herein are based on the current expectations and assumptions of NuVasive and not on historical facts. 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 NuVasive assumes no obligation to update any forward-looking statement to reflect events or circumstances arising after the date on which it was made.

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Investor/Media Contact:
Stacy Roughan
NuVasive, Inc.
[email protected]

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