CARLSBAD, Calif., July 11, 2019 (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 full commercial launch of the Regatta® Lateral System, featuring NanoMetalene® technology.
Regatta is a comprehensive, minimally invasive lateral interbody fusion system designed to efficiently and reproducibly treat the spine through indirect decompression and the restoration of sagittal alignment. The Regatta lateral retractor and the electromyography (EMG) nerve detection dilators allow for customizable access with minimal tissue disruption through the psoas, while also providing the visualization necessary to effectively perform the procedure.
“The Regatta Lateral System is the culmination of the extensive lateral expertise of our product development and marketing teams and the valuable surgeon input gained through a comprehensive alpha evaluation,” stated Dennis Cirino, Senior Vice President, Global Spinal Systems. “The full launch of Regatta allows us to make this important procedural solution available to more of our distribution partners and surgeons. We are confident that it will be an important driver of our future revenue growth, beginning in the second half of 2019.”
Leading up to the full launch of Regatta, SeaSpine conducted lateral sales training and surgeon education programs to ensure a positive customer experience with the new system. The Company also held its inaugural SeaSpine Lateral Summit, which brought together experienced lateral surgeons to explore the future of lateral spine surgery and is expected to be held on an annual basis.
The Regatta interbody devices feature proprietary NanoMetalene surface technology. NanoMetalene is a submicron layer of commercially pure titanium molecularly bonded to a PEEK implant using a high-energy, low-temperature process referred to as atomic fusion deposition. It is designed to provide a bone-friendly titanium surface on endplates and throughout graft apertures, while retaining the benefits associated with traditional PEEK implants, such as biocompatibility, a modulus of elasticity similar to bone, and excellent radiographic visibility for postoperative imaging.
Dr. Douglas Orndorff, orthopedic surgeon at Mercy Hospital, Durango, CO, stated, “Regatta provides me with a complete lateral solution that includes differentiated NanoMetalene surface technology. The streamlined instrumentation allows me to address the majority of my surgical correction goals, as well as challenging patient anatomies, with fewer trays. This elegant solution ultimately allows me to make interoperative decisions in an efficient and effective manner and provides a seamless workflow for my surgical staff.”
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 implants 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 implants portfolio consists of an extensive line of products to facilitate spinal fusion in degenerative, minimally invasive surgery (MIS), and complex spinal deformity procedures. Expertise in both orthobiologic sciences and spinal implants 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 approximately 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 of Regatta and its ability to efficiently and reproducibly treat the spine, including the ability to allow for customizable access with minimal tissue disruption while providing necessary visualization; the ability of Regatta to be an important driver of our future revenue growth, particularly in the second-half of 2019; training and education ensuring a positive customer experience and whether the Company will hold the SeaSpine Lateral Summit on an annual basis; and the ability of NanoMetalene surface technology to provide intended benefits. Among the factors that could cause or contribute to material differences between the Company’s actual results and the expectations indicated by the forward-looking statements are risks and uncertainties that include, but are not limited to: the ability of products entering full commercial launch, such as Regatta, to perform as designed and intended and to meet the needs of surgeons and patients, including as a result of limited clinical validation during “alpha” evaluation; the fact that products entering full commercial launch, such as Regatta, may require substantial additional development activities for issues not identified during alpha evaluation, which could introduce unexpected delay and expense; surgeon’s willingness to continue to use the Company’s existing products and other newly launched products; the Company’s ability to attract new, high-quality distributors; continued pricing pressure and exclusion from major healthcare systems; the risk of supply shortages and associated disruption to product sales, including as a result of the Company’s dependence on a limited number of third-party suppliers for components and raw materials and the Company’s reliance on a sole provider to apply NanoMetalene surface technology to its products, including Regatta; the Company’s ability to continue to invest in medical education and training, product development, and/or sales and marketing initiatives at levels sufficient to drive future revenue growth; general economic and business conditions in the markets in which the Company does business, both in the U.S. and abroad; and other risks and uncertainties more fully described in the Company’s 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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