SeaSpine Announces Limited Commercial Launch of Mariner MIS Wayfinder
SeaSpine Holdings Corporation (NASDAQ: SPNE) announced the limited commercial launch of the Mariner® MIS Wayfinder System, a novel k-wireless screw delivery system for pedicle screw fixation. The system aims to enhance surgical efficiency by eliminating traditional guidewires and providing real-time feedback, aligning with SeaSpine's Mariner platform. Early user feedback indicates significant operational efficiencies, particularly when used with the 7D FLASH Navigation System. The company continues to expand its product offerings in the spinal disorder treatment market.
- Launch of the Mariner MIS Wayfinder System, enhancing operational efficiency.
- Positive initial feedback from surgeons regarding the system's effectiveness when paired with the 7D FLASH Navigation System.
- Potential risks regarding the product's performance and effectiveness due to limited clinical validation.
- Need for further development and potential delays in obtaining regulatory clearances.
CARLSBAD, Calif., Nov. 01, 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 and completion of initial surgeries of the Mariner® MIS Wayfinder System.
Mariner MIS Wayfinder is a novel, one step, k-wireless screw delivery system for pedicle screw fixation. Mariner MIS Wayfinder eliminates reliance on traditional guidewires for percutaneous screw placement by providing a fully-integrated, surgeon-led solution that enables real-time feedback. This most recent launch reflects SeaSpine’s continued expansion of its Mariner platform and builds on the momentum from the limited commercial launch of the Mariner Adult Deformity System.
The Mariner MIS Wayfinder System embodies the design principles integral to the Mariner core philosophy, providing clinicians an innovative and intuitive approach to pedicle screw fixation, whether using traditional fluoroscopy or SeaSpine’s 7D FLASH Navigation System. “In the initial cases, the Mariner MIS Wayfinder System has already demonstrated significant efficiencies, particularly when paired with 7D technology,” said Shaeffer Bannigan, Senior Director of Product Development.
“Mariner MIS Wayfinder provides a one-step posterior percutaneous pedicle solution that eliminates need for stepwise pedicle access trocars and guidewires,” stated Dr. Erik Westerlund, MD, FACS, Chief of Surgery at Jack Hughston Memorial Hospital. “Wayfinder offers access to this new level of operative efficiency without attempting to over-engineer the surgeon out of the procedure. I find it to be yet another example of SeaSpine solutions aligning with my strategic and technical goal as a surgeon to drive the best possible outcomes for my patients.”
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, 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.
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 Mariner MIS Wayfinder System providing a fully-integrated, surgeon-led solution that enables real-time feedback, providing clinicians an innovative and intuitive approach to pedicle screw fixation, providing a one-step posterior percutaneous pedicle solution that eliminates need for stepwise pedicle access trocars and guidewires, and offering access to a new level of operative efficiency. 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, such as the Mariner MIS Wayfinder System, 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 in limited commercial (or “alpha”) launch; 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 Company’s ability to continue to invest in medical education and training for its newly launched products, including the Mariner MIS Wayfinder System; unexpected expense and delay, including as a result of developing and supporting the launch of new products; 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.
Investor Relations Contact
Hunter Cabi
(904) 304-9505
ir@seaspine.com
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