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SeaSpine Announces Full Commercial Launch of the 7D FLASH™ Navigation System Percutaneous Spine Module for Minimally Invasive Surgery

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SeaSpine Holdings Corporation (NASDAQ: SPNE) has launched the 7D FLASH™ Navigation System Percutaneous Spine Module, enhancing its capabilities in the minimally invasive spine surgery market valued at $4 billion globally. This system enables quick three-dimensional imaging for spinal procedures, improving efficiency and reducing radiation exposure. Surgeons have noted the versatility of the new module for various surgical approaches. The addition aims to increase adoption of the FLASH Navigation System across hospitals and surgical centers, expanding SeaSpine's market presence in surgical navigation.

Positive
  • Launch of the 7D FLASH Navigation System Percutaneous Spine Module enhances surgical capabilities.
  • Expansion into a $4 billion minimally invasive spine surgery market.
  • System improves efficiency of spinal procedures and reduces radiation exposure.
Negative
  • Forward-looking statements regarding adoption and performance may not materialize.
  • Potential risks related to novel imaging techniques may hinder system effectiveness.

CARLSBAD, Calif., Oct. 18, 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 7D FLASH™ Navigation System Percutaneous Spine Module. The release of the Percutaneous Module represents a new application and increased functionality for its 7D FLASH Navigation System, which now allows SeaSpine to further penetrate the minimally invasive spine surgery market, which SeaSpine estimates at approximately $4 billion worldwide.

“The addition of the Percutaneous Module to the FLASH Navigation System has brought versatility to my OR,” stated Dr. Douglas Orndorff of Spine Colorado.  “Whether I am performing mini-open procedures, large revision surgeries, or MIS fusions, I can do them all with one system that optimizes my workflows depending on my approach.  I’m also excited about the future launch of the Lumbar Facet Fusion system that will work seamlessly with the Percutaneous Module, enabling an integrated procedural solution for my patients.”

The 7D FLASH Navigation System uses visible light to create a three-dimensional image for surgical navigation in just seconds, which is expected to result in shorter and more efficient spinal procedures. It is the only marketed image-guidance system that utilizes novel and proprietary camera-based technology, coupled with machine-vision algorithms, to eliminate the long-standing frustrations with legacy surgical navigation platforms. The speed, accuracy, and efficiency of machine-vision technology is intended to provide significant economic value, lower radiation for staff and patients in open procedures, and harnesses the true potential of image-guided navigation – providing a truly unique offering for both open and minimally invasive spine procedures.

“Our Percutaneous Module has expanded the clinical functionality of the FLASH Navigation System by providing surgeons with a fully integrated procedural solution for minimally invasive surgery,” said Dr. Beau Standish, President of Enabling Technologies at SeaSpine. “This new application addresses a large and important part of the spine navigation market and should help drive adoption of our FLASH Navigation System among surgeons, hospitals and ambulatory surgery centers.”

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 future launch of the Company’s Lumbar Facet Fusion system and its ability to work with the Percutaneous Module; the expectation that the 7D FLASH Navigation System will result in shorter and more efficient spinal procedures; the ability of the 7D FLASH Navigation System to eliminate the long-standing frustrations with legacy surgical navigation platforms and to provide significant economic value and harnesses the true potential of image-guided navigation in surgical procedures; and the ability of the 7D Percutaneous Spine Module to help drive adoption of the FLASH Navigation System among surgeons, hospitals and ambulatory surgery centers.   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 the 7D FLASH Navigation System to perform as designed and intended and to meet the needs of surgeons and patients; risks inherent in the use of novel imaging techniques, including advanced optical technologies and machine vision-based registration algorithms; unexpected delays in the support and/or launch of the 7D Percutaneous Spine Module or other next generation or new applications of the 7D FLASH Navigation System, including the fact that newly launched products may require substantial additional development activities, which could introduce further delays, or 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
Greg Chodaczek
610-368-6505
ir@seaspine.com


FAQ

What is the 7D FLASH Navigation System launched by SeaSpine?

The 7D FLASH Navigation System is a surgical navigation platform designed to enhance efficiency and reduce radiation in spinal surgeries.

How does the new Percutaneous Spine Module impact spinal surgery?

The Percutaneous Spine Module allows for quicker imaging and improved workflow, making it suitable for various surgical approaches.

What market does SeaSpine aim to penetrate with the new navigation system?

SeaSpine aims to penetrate the $4 billion global minimally invasive spine surgery market.

What are the key benefits of the 7D FLASH Navigation System?

Key benefits include faster imaging, reduced radiation exposure, and improved accuracy in surgical navigation.

What risks are associated with the new 7D FLASH Navigation System?

Risks include potential performance issues and challenges with novel imaging techniques.

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