NuVasive(R) Receives Regulatory Shonin Approval to Broaden
NuVasive(R) Receives Regulatory Shonin Approval to Broaden Offering in Japan
SAN DIEGO, CA -- (Marketwire) -- 12/17/12 -- NuVasive, Inc. (NASDAQ: NUVA), a medical device company focused on developing minimally disruptive surgical products and procedures for the spine, announced today the Japanese approval of the CoRoent Large Impacted (LI) and CoRoent Large Tapered (LT) titanium alloy implants. The implants are used in posterior spine fusion procedures and are NuVasive's first two interbody fusion cages to be approved in Japan. The approvals further the Company's ability to participate in the world's second largest spine market with certain cervical solutions and a comprehensive posterior product offering, which have already been cleared for use.
Alex Lukianov, Chairman and CEO of NuVasive, said, "This is an exciting stepping stone for NuVasive! For several years, we have been thoughtfully laying the groundwork and making the investments to support a direct operation in Japan, a market estimated to be close to $400 million in size. We are proud to see all of those efforts coming to fruition so that our revenue ramp can begin in earnest at the start of the first quarter. We look forward to the opportunity to introduce Japanese surgeons and patients to NuVasive; first to our game changing portfolio of cervical and posterior thoraco-lumbar solutions, and then, upon further regulatory approval, to our unique lateral XLIF(R) solution."
NuVasive is a medical device company focused on developing minimally disruptive surgical products and procedurally integrated solutions for the spine. The Company is the 4th largest player in the $7.9 billion global spine market. NuVasive's principal product offering is based on its Maximum Access Surgery, or MAS(R) platform. The MAS platform combines several categories of solutions that collectively minimize soft tissue disruption during spine surgery with maximum visualization and safe, easy reproducibility for the surgeon: a proprietary software-driven nerve avoidance system and intra-operative monitoring support; MaXcess(R), a unique split-blade retractor system; a wide variety of specialized implants; and several biologic fusion enhancers. MAS significantly reduces surgery time and returns patients to activities of daily living much faster than conventional approaches. Having redefined spine surgery with the MAS platform's lateral approach, known as eXtreme Lateral Interbody Fusion, or XLIF(R), NuVasive has built an entire spine franchise. With over 75 products today spanning lumbar, thoracic and cervical applications, the Company will continue to expand and evolve its offering predicated on its R&D focus and dedication to outstanding service levels supported by a culture of Absolute Responsiveness(R).
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 NuVasive's revenue or earnings projections may turn out to be inaccurate because of the preliminary nature of the forecasts and the risk of further adjustment, or unanticipated difficulty in selling products or generating expected profitability; the uncertain process of seeking regulatory approval or clearance for NuVasive's products or devices, including risks that such process could be significantly delayed; the possibility that the FDA may require significant changes to NuVasive's products or clinical studies; the risk that products may not perform as intended and may therefore not achieve commercial success; the risk that competitors may develop superior products or may have a greater market position enabling more successful commercialization; the risk that additional clinical data may call into question the benefits of NuVasive's products to patients, hospitals and surgeons; 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 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.
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