SeaSpine Announces CE Mark Certification of 7D Surgical Cranial Module and Percutaneous Spine Module for Minimally Invasive Spine Surgery

Sep 27, 2021

CARLSBAD, Calif., Sept. 27, 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 it received simultaneous CE Mark certification for its Cranial Module and Percutaneous Spine Module for the 7D FLASH™ Navigation System. This achievement expands the applications and functionality of the FLASH Navigation System for cranial surgery and minimally invasive spine surgery for the European market and additional global regions.

“We are thrilled to achieve CE marking on the expanded applications for cranial and spine,” said Beau Standish, President of Enabling Technologies at SeaSpine. “The speed, accuracy, and efficiency of our Cranial Module has had a significant impact on surgical workflow and has strongly resonated with our surgeon customers in the US. In addition, the Percutaneous Spine Module rounds out our game-changing spine portfolio and help to address an important part of the spine navigation market. We are eager to deliver the expanded portfolio of our FLASH Navigation System as we strategically roll-out the technology to Europe.”

The 7D FLASH Navigation System uses visible light to create a three-dimensional image for surgical navigation in just seconds, resulting in shorter and more efficient spinal and cranial procedures. It is the only regulatory approved image guidance system that utilizes this novel and proprietary camera-based technology, coupled with machine-vision algorithms, to eliminate the long-standing frustrations with legacy surgical navigation platforms. Specific to cranial applications, the FLASH Navigation System uses a completely contactless workflow, acquiring hundreds of thousands of virtual fiducials using the patient’s own anatomy, resulting in nearly instantaneous cranial registrations in almost any surgical position. The speed, accuracy, and efficiency of the FLASH Navigation Machine-Vision technology is intended to provide significant economic value and harnesses the true potential of image guided navigation for spinal and cranial surgery.

“The CE marking of these expanded applications is an important milestone as we look to further penetrate the European market with these best-in-class technologies,” stated Keith C. Valentine, President and Chief Executive Officer at SeaSpine. “The FLASH Navigation portfolio continues to deliver immense clinical value to the surgeon, hospital, and patient. We look forward to the continued development of our strong innovation pipeline to share with our customers from around the world and demonstrate our innovative philosophy and approach to improving surgical outcomes.”

About SeaSpine
SeaSpine ( 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.

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 opportunity to expand the application of 7D Surgical’s technology to other surgical specialties; the ability for 7D Surgical to accelerate the development of additional software and systems; and the ability of the Company to expand its market share. 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 Company to develop and launch products that perform as designed that meet the needs of surgeons and patients; unexpected delays in the development and support of the launch of new products, 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

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

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Source: SeaSpine Holdings Corporation