09 Jun SeaSpine Announces Limited Commercial Launch of the WaveForm® L (Lateral) 3D-Printed Interbody System
CARLSBAD, Calif., June 08, 2021 (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 its 3D-printed WaveForm L (Lateral) Interbody System.
WaveForm L is designed for the LLIF (lateral lumbar interbody fusion) procedure, and seamlessly integrates with the entire Regatta NanoMetalene® lateral interbody portfolio, including the recently launched Regatta Lateral Plate. WaveForm L delivers a fully porous interbody solution with a graft aperture designed to accommodate a large amount of SeaSpine’s best-in-class allograft demineralized bone matrix offerings OsteoStrand® and OsteoStrand® Plus.
“The WaveForm L implant from SeaSpine is one of the best new lateral cages currently on the market,” said Douglas Orndorff, Orthopedic surgeon, Durango, CO. “It incorporates the new 3D-printed technology with amazing gyroid geometry and optimum pore size for fusion. In addition, it has a large internal hollow core that allows surgeons to place a large amount of orthobiologics material into the core. This design can allow for a considerable amount of bony fusion throughout the entire cage.”
The WaveForm L interbody offers the next level of 3D-printed architectural innovation, balancing key geometric and manufacturing advancements without compromising clinical requirements. WaveForm L utilizes innovative WaveForm technology to deliver a highly porous and robust interbody solution. This design is intended to balance subsidence resistance, implant stiffness, and orthobiologics packability, while maintaining radiographic visualization during intraoperative and postoperative imaging.
“WaveForm L is our fourth entry into the 3D-printed interbody space, with the launch of a fifth implant for ALIF (anterior lumbar interbody fusion) procedures planned in the coming months,” said Dennis Cirino, Senior Vice President of Global Spinal Systems. “This new lateral system is the accumulation of decades of experience in lateral interbody design and orthobiologics that captures significant efficiencies from sharing the same instrumentation with our existing Regatta system. With an extensive ability to pack orthobiologics in and around its innovative graft aperture, Waveform L also maximizes endplate contact without compromising strength or radiolucency. We are excited to continue building out our WaveForm portfolio as we expand our procedural footprint.”
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, as well as a market leading surgical navigation system, 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 orthobiologic sciences, as well as spinal implants, software, and advanced optics 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 through a committed network of increasingly exclusive distribution partners.
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 this year in the 3D-printed interbody space; the design of WaveForm L and its ability to balance key geometric and manufacturing advancements without compromising clinical utility; and 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 L, 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 L, 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: Globe Newswire, 8th June 2021