SAN DIEGO, CA, Dec 17, 2012 (Menafn - MARKETWIRE via COMTEX) --NuVasive, Inc. NUVA, a medical device company focused ondeveloping minimally disruptive surgical products and procedures forthe spine, announced today the Japanese approval of the CoRoent LargeImpacted (LI) and CoRoent Large Tapered (LT) titanium alloy implants.The implants are used in posterior spine fusion procedures and areNuVasive's first two interbody fusion cages to be approved in Japan.The approvals further the Company's ability to participate in theworld's second largest spine market with certain cervical solutionsand a comprehensive posterior product offering, which have alreadybeen cleared for use.
Alex Lukianov, Chairman and CEO of NuVasive, said, "This is anexciting stepping stone for NuVasive! For several years, we have beenthoughtfully laying the groundwork and making the investments tosupport a direct operation in Japan, a market estimated to be closeto 400 million in size. We are proud to see all of those effortscoming to fruition so that our revenue ramp can begin in earnest atthe start of the first quarter. We look forward to the opportunity tointroduce Japanese surgeons and patients to NuVasive; first to ourgame changing portfolio of cervical and posterior thoraco-lumbarsolutions, and then, upon further regulatory approval, to our uniquelateral XLIF(R) solution."
NuVasive is a medical device company focused on developing minimallydisruptive surgical products and procedurally integrated solutionsfor the spine. The Company is the 4th largest player in the 7.9billion global spine market. NuVasive's principal product offering isbased on its Maximum Access Surgery, or MAS(R) platform. The MASplatform combines several categories of solutions that collectivelyminimize soft tissue disruption during spine surgery with maximumvisualization and safe, easy reproducibility for the surgeon: aproprietary software-driven nerve avoidance system andintra-operative monitoring support; MaXcess(R), a unique split-bladeretractor system; a wide variety of specialized implants; and severalbiologic fusion enhancers. MAS significantly reduces surgery time andreturns patients to activities of daily living much faster thanconventional approaches. Having redefined spine surgery with the MASplatform's lateral approach, known as eXtreme Lateral InterbodyFusion, or XLIF(R), NuVasive has built an entire spine franchise.With over 75 products today spanning lumbar, thoracic and cervicalapplications, the Company will continue to expand and evolve itsoffering predicated on its R&D focus and dedication to outstandingservice levels supported by a culture of Absolute Responsiveness(R).
NuVasive cautions you that statements included in this press releasethat are not a description of historical facts are forward-lookingstatements that involve risks, uncertainties, assumptions and otherfactors which, if they do not materialize or prove correct, couldcause NuVasive's results to differ materially from historical resultsor those expressed or implied by such forward-looking statements. Thepotential risks and uncertainties that could cause actual growth andresults to differ materially include, but are not limited to: therisk that NuVasive's revenue or earnings projections may turn out tobe inaccurate because of the preliminary nature of the forecasts andthe risk of further adjustment, or unanticipated difficulty inselling products or generating expected profitability; the uncertainprocess of seeking regulatory approval or clearance for NuVasive'sproducts or devices, including risks that such process could besignificantly delayed; the possibility that the FDA may requiresignificant changes to NuVasive's products or clinical studies; therisk that products may not perform as intended and may therefore notachieve commercial success; the risk that competitors may developsuperior products or may have a greater market position enabling moresuccessful commercialization; the risk that additional clinical datamay call into question the benefits of NuVasive's products topatients, hospitals and surgeons; and other risks and uncertaintiesmore fully described in NuVasive's press releases and periodicfilings with the Securities and Exchange Commission. NuVasive'spublic filings with the Securities and Exchange Commission areavailable at www.sec.gov. NuVasive assumes no obligation to updateany forward-looking statement to reflect events or circumstancesarising after the date on which it was made.
Michael J. Lambert
EVP & Chief Financial Officer
VP, Corporate Development & Investor Relations
Nicholas S. Laudico
The Ruth Group