SeaSpine Announces Full Commercial Launch of the Mariner MIS Wayfinder System
SeaSpine Holdings Corporation (NASDAQ: SPNE) announced the full commercial launch of the Mariner MIS Wayfinder System on October 31, 2022. This innovative k-wireless screw delivery system simplifies pedicle screw fixation by eliminating traditional guidewires, offering a fully integrated solution for minimally invasive spinal surgery. The system is compatible with the 7D FLASH™ Navigation System, enhancing surgical efficiency. Key industry figures praise the tool’s ergonomic design and user-friendliness, marking a significant advancement in spinal disorder treatment.
- Launch of the Mariner MIS Wayfinder System enhances minimally invasive surgery capabilities.
- Integration with 7D FLASH™ Navigation System improves surgical efficiency.
- Industry experts commend the ergonomic design and ease of use for surgeons.
- Potential risks associated with the performance of newly launched products due to lack of substantial clinical validation.
- Need for additional development activities could introduce further delays and expenses.
- Dependence on market acceptance and regulatory clearances may pose challenges.
CARLSBAD, Calif., Oct. 31, 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 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 leverages the strength and versatility of SeaSpine’s foundational Mariner modular pedicle screw technology.
Mariner MIS Wayfinder is fully integrated with the 7D FLASH™ Navigation System’s recently launched FLASH Percutaneous module. FLASH Percutaneous addresses the minimally invasive spine surgery market and facilitates a fast, efficient, and simple workflow that complements Mariner MIS Wayfinder’s all-in-one modality, making it an optimal solution for MIS spinal fusion procedures.
“Thoughtful and efficient instrumentation design in Mariner MIS Wayfinder delivers the capability to significantly reduce the number of steps associated with fixation placement,” said Azam Basheer, M.D., Neurosurgeon at Henry Ford Health in Jackson, MI. “Combined with the outstanding functionality of Mariner MIS and FLASH Navigation’s recently-launched percutaneous module, SeaSpine now offers a market-leading procedural solution.”
“Mariner MIS Wayfinder has been a powerful addition to the Mariner platform,” stated Mike Hall, Vice President, Marketing. “This effective tool is ergonomic and provides a highly user-friendly solution for surgeons using this emerging technique.”
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’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.
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
Greg Chodaczek
610-368-6505
ir@seaspine.com
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