23 Feb SeaSpine Announces Limited Commercial Launch of WaveForm™ TA (TLIF Articulating) 3D-Printed Interbody System
CARLSBAD, Calif., Feb. 22, 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 TA (TLIF Articulating) Interbody Implant System. WaveForm TA represents SeaSpine’s first 3D-printed lumbar interbody system and follows the September 2020 launch of its WaveForm C Interbody Implant System, designed to be used in ACDF (anterior cervical discectomy fusion) procedures. SeaSpine will be launching three additional 3D-printed interbody systems by mid-2021.
“I am a strong believer in 3D-printed interbody technology and SeaSpine’s WaveForm TA is the ideal implant for this area of my practice. I really like the porosity of the implant and the gyroid design is unique and like no other implant on the market,” said Dr. Alex Mohit of NeoSpine and Tacoma General Hospital. “The instrumentation is simple and intuitive, and the variety of implant sizes helps me tailor treatment for my patients.”
The WaveForm TA implant offers the next level of 3D-printed architectural innovation, balancing key geometric and manufacturing advancements without compromising clinical requirements. WaveForm TA utilizes innovative WaveForm technology to deliver a highly porous and robust interbody solution. WaveForm TA features 65% porous endplates* and 75% porous architecture within the body* of the implant. This design is intended to balance subsidence resistance, implant stiffness, and bone graft packability, while maintaining radiographic visualization during intraoperative and postoperative imaging.
“The addition of 3D implants to our lumbar interbody portfolio in 2021 represents our commitment to continue raising the bar in the lumbar interbody space, providing more options to surgeons with thoughtfully designed implants that combine our proprietary surface technologies with next-gen engineering,” stated Sarah Stoltz, Senior Manager of Engineering.
WaveForm TA is designed to be used in TLIF (transforaminal lumbar interbody fusion) procedures. The system includes multiple footprints and lordotic options, allowing surgeons the ability to intraoperatively address specific anatomical needs. The 3D-printed interbody devices utilize the same instrumentation as the Reef™ TA Interbody System that SeaSpine launched in 2020. By deliberately designing best-in-class instruments to be utilized with two different surface technologies, such as WaveForm and Reef Topography™, SeaSpine is minimizing instruments required to be onsite at the hospital yet giving surgeons the options that they prefer.
*Data on file
About SeaSpine
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 through a committed network of increasingly exclusive distribution partners.
Forward-Looking Statements
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 3D-printed interbody devices that the Company will be launching by mid-2021; and the objectives of product design and the ability of the underlying products to achieve design objectives, including balancing subsidence resistance, implant stiffness, and orthobiologics packability, while maintaining radiographic visualization during intraoperative and postoperative imaging; allowing surgeons the ability to intraoperatively address specific anatomical needs; and minimizing instruments required to be onsite at the hospital, while giving surgeons the options that they prefer. 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 (and associated instruments) 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.
Investor Relations Contact
Leigh Salvo
(415) 937-5402
ir@seaspine.com