SeaSpine Announces Full Commercial Launch of the WaveForm™ TO (TLIF Oblique) 3D-Printed Interbody System
Company’s first full commercial launch of novel 3D printed interbody product franchise that addresses estimated $500 million market opportunity
CARLSBAD, Calif., June 08, 2022 (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 its 3D-printed WaveForm TO (TLIF Oblique) Interbody System.
WaveForm TO was designed for both PLIF (posterior lumbar interbody fusion) and TLIF (transforaminal lumbar interbody fusion) procedures. The system accommodates both direct impact insertion and insert-and-rotate techniques. With a comprehensive set of decompression, disc preparation, and implant insertion instruments that are compatible with the NanoMetalene-based Reef TO system, WaveForm TO provides a versatile lumbar interbody solution for surgeons.
“It remains essential to have interbody implants that cumulatively participate in the index biologic fusion response - always advancing the goal of stable osseous union,” said Dr. Erik Westerlund of Jackson Hughston Memorial Hospital in Alabama. “In this context, Waveform TO represents a uniquely-optimized porous titanium TLIF interbody solution. This refined design incorporates a 3D-printed open gyroid architecture that maintains implant strength while simultaneously providing a favorable fusion environment.”
WaveForm interbody devices offer the next level of 3D-printed architectural innovation, balancing key geometric and manufacturing advancements without compromising clinical requirements. WaveForm TO utilizes innovative WaveForm technology to deliver a highly porous and yet robust interbody solution, with a design intended to optimize subsidence resistance, implant stiffness, and orthobiologics packability, while maintaining radiographic visualization during intraoperative and postoperative imaging.
“WaveForm TO is our first 3D Interbody to commercially launch, with more launches planned before the end of this year,” said Dennis Cirino, Senior Vice President of Global Spinal Systems. “Designed for strength, radiolucency, and an unparalleled ability to pack orthobiologics due to its innovative design. WaveForm TO is a comprehensive, intuitive, and reliable system capable of addressing multiple patient pathologies. With this launch we have an opportunity to address an additional $500 million market opportunity with this best-in-class technology.”
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 number of additional launches the Company plans before the end of this year in the 3D-printed interbody space; the design of WaveForm TO and its ability to provide a versatile lumbar interbody solution for surgeons; the ability of WaveForm TO to balance key geometric and manufacturing advancements without compromising clinical utility; the ability of WaveForm technology to deliver a highly porous and robust interbody solution and appropriately balance subsidence resistance, implant stiffness, and orthobiologics packability, while maintaining radiographic visualization during intraoperative and postoperative imaging. 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: unexpected expense and delay, including as a result of developing and supporting the launch of new products, such as Waveform TO, the fact that newly launched products may require substantial additional development activities, which could introduce further expense and delay, or as a result of delay in timely obtaining regulatory clearances; the ability of newly launched products, such as WaveForm TO, to perform as designed and intended and to meet the needs of surgeons and patients, including as a result of the lack of substantial clinical validation of products following limited commercial (or “alpha”) launch; 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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Source: SeaSpine Holdings Corporation
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