Indications for Use:LATIS™ Spacers are interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). LATIS™ Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation. About Globus Medical, Inc. Globus Medical, Inc. is a leading musculoskeletal implant company based in Audubon, PA. The company was founded in 2003 by an experienced team of professionals with a shared vision to create products that enable surgeons to promote healing in patients with musculoskeletal disorders. Additional information can be accessed at www.globusmedical.com. Safe Harbor Statements All statements included in this press release other than statements of historical fact are forward-looking statements and may be identified by their use of words such as “believe,” “may,” “might,” “could,” “will,” “aim,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “plan” and other similar terms. These forward-looking statements are based on our current assumptions, expectations and estimates of future events and trends. Forward-looking statements are only predictions and are subject to many risks, uncertainties and other factors that may affect our businesses and operations and could cause actual results to differ materially from those predicted. These risks and uncertainties include, but are not limited to, factors affecting our quarterly results, our ability to manage our growth, our ability to sustain our profitability, demand for our products, our ability to compete successfully (including without limitation our ability to convince surgeons to use our products and our ability to attract and retain sales and other personnel), our ability to rapidly develop and introduce new products, our ability to develop and execute on successful business strategies, our ability to comply with changing laws and regulations that are applicable to our businesses, our ability to safeguard our intellectual property, our success in defending legal proceedings brought against us, trends in the medical device industry, general economic conditions, and other risks. For a discussion of these and other risks, uncertainties and other factors that could affect our results, you should refer to the disclosure contained in our most recent annual report on Form 10-K filed with the Securities and Exchange Commission, including the sections labeled “Risk Factors” and “Cautionary Note Concerning Forward-Looking Statements,” and in our Form 10-Q, Form 8-K and other filings with the Securities and Exchange Commission. These documents are available at www.sec.gov. Moreover, we operate in an evolving environment. New risk factors and uncertainties emerge from time to time and it is not possible for us to predict all risk factors and uncertainties, nor can we assess the impact of all factors on its business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Given these risks and uncertainties, readers are cautioned not to place undue reliance on any forward-looking statements. Forward-looking statements contained in this press release speak only as of the date of this press release. We undertake no obligation to update any forward-looking statements as a result of new information, events or circumstances or other factors arising or coming to our attention after the date hereof.
Globus Medical, Inc. (NYSE: GMED), a leading spinal implant manufacturer, today announced the launch of LATIS™, a minimally invasive (MIS) lumbar interbody fusion spacer for patients suffering from degenerative disc disease. The implant may be inserted through an MIS transforaminal lumbar interbody fusion (TLIF) approach and expands laterally to provide a footprint and graft volume equivalent to an anterior lumbar interbody fusion (ALIF) spacer or lateral lumbar interbody fusion (LLIF) spacer.
LATIS(TM), Globus Medical (Photo: Globus Medical, Inc.)The LATIS™ spacer provides a large stable footprint and a substantial graft window, benefits typical of an ALIF or LLIF spacer, without requiring anterior access or nerve monitoring, and allows for direct decompression of nerve roots via the MIS TLIF approach. The 10mm-wide titanium implant can be inserted posteriorly and can expand in-situ up to 26mm square, offering the largest single bone graft chamber for any posterior implant on the market. Designed to reduce subsidence and migration, the spacer has a locking set screw that secures deployment at any position within the expansion range. The LATIS™ system includes customized disc preparation and sizing instruments to simplify the procedure for an efficient MIS TLIF approach. The system includes a variety of footprints, heights, and lordotic configurations, for a customized fit for each patient. A single instrument is used for insertion, expansion, locking, and bone graft delivery. “This new addition to our MIS portfolio is the first expandable implant on the market to offer the benefits of a traditional anterior implant, without the two-part disruptive surgical procedure. Combined with posterior stabilization using our REVOLVE® MIS pedicle screw system, the entire procedure is designed and intended to maximize preservation of the stabilizing muscles of the lower back,” commented Andrew Iott, Senior Vice President, Global Product Development.