SAN DIEGO, CA--(Marketwire - Feb 26, 2013) - NuVasive, Inc. (
NuVasive has received regulatory Shonin approval for several products to offer the XLIF surgical technique as a minimally invasive option for lumbar spine fusion to patients and surgeons in Japan. The approval furthers the Company's ability to participate in the Japanese market, adding the XLIF approach to the cervical and posterior products that were approved for use late last year.
Russell Powers, NuVasive Executive Vice President of International, said, "We are absolutely thrilled that NuVasive now offers our comprehensive portfolio of innovative, procedurally integrated solutions for spine surgery in Japan, including XLIF. The XLIF procedure changed spine surgery in the U.S. with a minimally invasive approach designed to achieve reproducible, superior patient outcomes. We are eager to introduce XLIF across Japan, and to drive the shift toward minimally invasive approaches in the world's second largest spine market. Our initial reception in Japan has been fantastic, and I applaud all of the NuVasive teams who worked to establish our Absolutely Responsive direct operation in this exciting new market."
XLIF is a minimally invasive surgical (MIS) procedure performed through the side of the body utilizing proprietary neuromonitoring and an integrated portfolio of instruments and specialized implants for treating a range of spinal pathologies.
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 $8.2 billion global spine market. NuVasive's principal product offering is based on its Maximum Access Surgery, or MAS® 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®, 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®, NuVasive has built an entire spine franchise. With over 80 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®.
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.