SAN DIEGO, Oct. 24 /PRNewswire-FirstCall/ -- NuVasive, Inc. , a medical device company focused on developing products for minimally disruptive surgical treatments for the spine, announced today that it filed for an Investigational Device Exemption (IDE) from the United States Food and Drug Administration (FDA) to investigate the safety and efficacy of its NeoDisc(TM) cervical nucleus-like replacement device. FDA approval of the IDE from the FDA would allow the Company to initiate a pivotal human clinical study of the device in the U.S.
NeoDisc is a nucleus-like replacement device designed to preserve motion in the cervical region of the spine and fills the gap between pre-surgical treatment and Total Disc Replacement (TDR) or spinal fusion. NuVasive believes that NeoDisc will be attractive for use in broad indications and pathologies because it is easily revisable and is intended to involve a relatively simple surgical placement procedure. Additionally, the potential to treat patients earlier in the degenerative cascade could make the NeoDisc an attractive surgical option.
Alexis V. Lukianov, Chairman and Chief Executive Officer, said, “The IDE filing for U.S. clinical trials of NeoDisc is a major milestone for NuVasive’s motion preservation product efforts. It represents our commitment to moving into the cervical motion preservation market as an important corporate objective. We believe that if FDA approval is obtained, the NeoDisc device, coupled with our Cerpass(TM) TDR product in development, could provide us with a comprehensive offering for the preservation of motion for the cervical spine.”
About NuVasive
NuVasive is a medical device company focused on the design, development and marketing of products for the surgical treatment of spine disorders. The Company’s product portfolio is focused on applications in the over $2 billion U.S. spine fusion market. The Company’s current principal product offering includes a minimally disruptive surgical platform called Maximum Access Surgery, or MAS(TM), as well as classic fusion implants.
MAS combines three categories of current product offerings-NeuroVision(R), a proprietary software-driven nerve avoidance system; MaXcess(R), a unique split-blade design retraction system; and specialized implants, like SpheRx(R) and CoRoent(TM)-that collectively minimize soft tissue disruption during spine surgery while allowing maximum visualization and surgical reproducibility. NuVasive’s classic fusion portfolio is comprised predominantly of proprietary saline packaged bone allografts and internal fixation products. NuVasive also has a robust R&D pipeline emphasizing both MAS and motion preservation products such as Total Disc Replacement (TDR) and a nucleus-like cervical disc replacement.
NuVasive cautions you that statements included in this press 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 that could cause actual growth and results to differ materially include, but are not limited to: the risk that additional clinical experience may demonstrate that NuVasive’s products do not provide the intended safe and reproducible results; the uncertain process of seeking regulatory approval or clearance for NuVasive’s products, including the risk that such process could be significantly delayed or ultimately unsuccessful; the risk that the FDA may require significant changes to the proposed clinical study protocol or the products; the risk that competitors may develop superior products or may have a greater market position enabling more successful commercialization; and other risks and uncertainties more fully described in NuVasive’s press releases and periodic filings with the Securities and Exchange Commission. NuVasive’s public filings with the Securities and Exchange Commission are available at http://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.
Contact: Investors: Kevin C. O’Boyle Stephanie Carrington/Nick Laudico EVP & Chief Financial Officer The Ruth Group NuVasive, Inc. 646-536-7017/7030 858-909-1800 scarrington@theruthgroup.cominvestorrelations@nuvasive.comnlaudico@theruthgroup.com
NuVasive, Inc.
CONTACT: Kevin C. O’Boyle, EVP & Chief Financial Officer of NuVasive,Inc., +1-858-909-1800, investorrelations@nuvasive.com; or StephanieCarrington, +1-646-536-7017, scarrington@theruthgroup.com, or Nick Laudico,+1-646-536-7030, nlaudico@theruthgroup.com, both of The Ruth Group forNuVasive, Inc.
