CARLSBAD, Calif., July 13, 2017 (GLOBE NEWSWIRE) -- SeaSpine Holdings Corporation (NASDAQ:SPNE), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, today announced the limited commercial launch of and completion of initial cases for its Skipjack Expandable Interbody System.
Skipjack is an expandable interbody system based on patented technology acquired as part of the NLT transaction announced in August 2016. Skipjack is designed to provide continuous in-situ expansion in either height or lordosis for a tailored anatomical fit. Skipjack adds to SeaSpine’s portfolio of differentiated solutions within the interbody device market, which is estimated to be one of the fastest growing segments of the U.S. spinal instrumentation market. Notably, Skipjack implants provide up to 20 degrees of lordotic correction from a posterior approach and are accompanied by integrated graft delivery instrumentation to post-pack the implant and surrounding disc space.
“The alpha launch of Skipjack reflects the culmination of our ability to identify and acquire novel technologies and combine it with our surgeon-focused development and marketing expertise to rapidly bring innovative new products to market,” said Keith Valentine, President and Chief Executive Officer of SeaSpine. “In surgeon-responsive and rapid fashion, SeaSpine has translated NLT’s intellectual property into what we believe will be high clinical-value products that contribute to improving patient lives.”
Skipjack provides surgeons the ability to place smaller implants that expand within the interbody space, potentially enabling smaller incisions and more limited nerve retraction without sacrificing the advantages of larger, but more disruptive, implants. This in-situ expansion is intended to reduce tissue disruption, minimize endplate damage and, thereby, improve patient outcomes.
“The parallel and lordotic options that Skipjack offers allow me to expand in-situ for a more patient-specific fit. The initial stability is excellent and being able to backfill the cage with the same set of instruments helps simplify the procedure,” stated Dr. James Brennan, Sentara Virginia Beach Hospital.
SeaSpine (www.seaspine.com) is a global medical technology company focused on the design, development and commercialization of surgical solutions for the treatment of patients suffering from spinal disorders. SeaSpine has a comprehensive portfolio of orthobiologics and spinal instrumentation solutions to meet the varying combinations of products that neurosurgeons and orthopedic spine surgeons need to perform fusion procedures on the lumbar, thoracic and cervical spine. SeaSpine’s orthobiologics products consist of a broad range of advanced and traditional bone graft substitutes that are designed to improve bone fusion rates following a wide range of orthopedic surgeries, including spine, hip, and extremities procedures. SeaSpine’s spinal instrumentation portfolio consists of an extensive line of products to facilitate spinal fusion in minimally invasive surgery (MIS), complex spine, deformity and degenerative procedures. Expertise in both orthobiologic sciences and spinal instrumentation product development allows SeaSpine to offer its surgeon customers a differentiated portfolio and a complete solution to meet their fusion requirements. SeaSpine currently markets its products in the United States and in over 30 countries worldwide.
SeaSpine cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that are based on the Company's current expectations and assumptions. Such forward-looking statements include, but are not limited to, statements relating to: the design and other potential benefits of the Skipjack Expandable Interbody System, including its providing a tailored anatomical fit, its differentiation and ability to compete in the interbody device market, its ability to enable smaller incisions, limit nerve retraction, reduce tissue disruption and minimize endplate damage, and its clinical value and ability to improve patient lives. Among the factors that could cause or contribute to material differences between our actual results and the expectations indicated by our forward-looking statements are risks and uncertainties that include, but are not limited to: the fact that the Skipjack Expandable Interbody System has not been validated clinically, may not address adequately surgeon requirements, and may require substantial additional development activities, which could introduce unexpected expense and delay, including potentially requiring resubmission of one or more products to FDA for clearance, which clearance cannot be certain, whether on a timely basis or at all; surgeons’ willingness to use the Skipjack Expandable Interbody System; the risk that the Skipjack Expandable Interbody System may not demonstrate adequate safety or efficacy, independently or relative to competitive products, to support a full commercial launch; the risk of supply shortages, including as a result of our dependence on a limited number of third-party suppliers for components and raw materials, or otherwise; and other risks and uncertainties more fully described in our news releases and periodic filings with the Securities and Exchange Commission. The Company’s public filings with the Securities and Exchange Commission are available at www.sec.gov.
You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date when made. SeaSpine does not intend to revise or update any forward-looking statement set forth in this news release to reflect events or circumstances arising after the date hereof, except as may be required by law.
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