SeaSpine Holdings Corporation (NASDAQ: SPNE), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, today announced the successful completion of the first cases in both the United States and Australia for the 7D Percutaneous Spine Module. The release of the Percutaneous Module represents a new application and increased functionality for its 7D Flash™ Navigation System that allows SeaSpine to address the minimally invasive spine surgery market, which SeaSpine estimates at approximately $4 billion worldwide.
“The addition of the 7D Percutaneous Module now allows me to effectively navigate MIS procedures with a high level of accuracy and efficiency on 7D’s intuitive user interface, whilst significantly reducing intraoperative radiation exposure to the surgical team when compared to standard fluoroscopy targeting,” said Dr. Michael Selby, orthopedic surgeon at Adelaide Brain & Spine in Melbourne, Australia, who was the first surgeon in the world to use the Percutaneous Module in a clinical setting. “As a spine surgeon who treats an extensive range of complex degenerative and deformity pathologies, the addition of the Perc Module to the 7D FLASH Navigation System enables me to truly optimize my spine navigation workflow, specific to the approach that is most suitable for the procedure that I am performing.”
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 and harnesses the true potential of image-guided navigation in surgical procedures.
“We are extremely excited to have our first clinical cases completed with the Percutaneous Module,” said Beau Standish, President of Enabling Technologies at SeaSpine. “This new application will help address a very important part of the spine navigation market and will be a valuable enhancement for both hospitals and ambulatory surgery centers.”
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 and enabling technologies 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 and software 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.
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 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 address a very important part of the spine navigation market and be a valuable enhancement for both 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.
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