SeaSpine® Announces Full Commercial Launch of WaveForm® C
CARLSBAD, Calif., June 21, 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 the WaveForm C Interbody System.
The WaveForm C Interbody System, SeaSpine’s first cervical 3D-printed interbody, has the highest strength-to-porosity ratio compared to other 3D-printed structures1 due to its proprietary continuous wave-like structure. This interbody system addresses an over $200 million market opportunity. WaveForm C interbodies feature a 65% endplate porosity to facilitate early stability2 and 75% body porosity for graft flowability/packability, decreased stiffness, and improved imaging.
“WaveForm C employs a unique, sheet-based architecture. Years of research have led to this structure, which balances strength, porosity, and surface area, while enabling flowability of our best-in-class DBM fibers product, OsteoStrand® Plus. This feature combination offers what we believe to be market-leading clinical value in an effort to drive fusion,” said Ryan Pearson, Senior Director of Marketing, Cervical.
WaveForm C is cleared to be used in multiple contiguous levels with Shoreline® TruProfile® plating or with the Admiral™ anterior cervical plate. The WaveForm C system includes multiple footprints and lordosis options, allowing surgeons the ability to address specific anatomical needs.
“WaveForm C is the most advanced 3D-printed cervical interbody on the market.” said Dr. Erik Olsson, of UNC Health. “The streamlined design allows for efficient insertion and flexibility with plate placement, while the porosity and surface structure provide an optimal environment for fusion, especially paired with OsteoStrand® Plus fibers.”
1O. Al-Ketan, R. Rowshan, R.K. Abu Al-Rub, Topology-mechanical property relationship of 3D printed strut, skeletal, and sheet based periodic metallic cellular materials, Addit. Manuf. 19 (2018) 167–183.
2C.N. Kelly, et al., High-strength, porous additively manufactured implants with optimized mechanical osseointegration, Acta Biomater. 279 (2021).
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’s complete procedural solutions feature its market-leading FLASH™ Navigation, a system designed to improve accuracy of screw placement and provide a cost-effective, rapid, radiation-free solution to surgical navigation, and a comprehensive portfolio of spinal implants and orthobiologics to meet the varying combinations of products that neurosurgeons and orthopedic spine surgeons need to facilitate spinal fusion in degenerative, minimally invasive surgery (MIS), and complex spinal deformity procedures on the lumbar, thoracic and cervical spine. With product development expertise in advanced optics, software, orthobiologic sciences and spinal implants, SeaSpine can offer its surgeon customers a complete solution to meet their patients’ evolving clinical needs. 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 objectives of product design and the ability of the underlying products to achieve design objectives, including to have the highest strength-to-porosity ratio compared to other 3D printed structures; to have graft flowability; to decrease stiffness; to improve imaging; and to facilitate early stability. 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 newly launched products to perform as designed and intended and to meet the needs of surgeons and patients, including as a result of the lack of clinical validation of products in limited commercial (or “alpha”) launch; unexpected delay, including as a result of developing and supporting the launch of new products, including as a result of obtaining regulatory clearances; 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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