SeaSpine Announces FDA 510(k) Clearance of OsteoBallast™ Demineralized Bone Matrix in Resorbable Mesh

CARLSBAD, Calif., Nov. 30, 2017 -- SeaSpine Holdings Corporation (NASDAQ:SPNE), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, today announced that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for use of its OsteoBallast™ Demineralized Bone Matrix (DBM) in Resorbable Mesh.

The OsteoBallast product is the latest innovation in SeaSpine’s orthobiologics portfolio that is designed to facilitate fusion.  OsteoBallast, which consists of a resorbable mesh containing 100% DBM without a carrier, simplifies graft placement and helps prevent graft migration while maximizing DBM content. OsteoBallast is designed to provide surgeons with a simple means for delivering bone graft in posterior spine surgery that contours to the local anatomy while maintaining shape and volume under compression. The simplified technique is particularly valuable in MIS procedures, where placing the graft accurately through tubes and small incisions can be challenging.

“This product demonstrates SeaSpine’s continued commitment to innovation and our focus on delivering improved procedural spine solutions and clinical value through cost-effective orthobiologics,” commented Tyler Lipschultz, SeaSpine’s Vice President of Orthobiologics and Business Development. “Coupled with the recent launch of our OsteoStrand™ Demineralized Bone Fibers product and our established Accell Bone Matrix (ABM) technology, SeaSpine now can offer surgeons additional options to address the varied needs of their patients.”

SeaSpine plans to launch the OsteoBallast product with a limited release by year-end and full commercial launch by mid-2018.

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 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 implant portfolio consists of an extensive line of products to facilitate spinal fusion in minimally invasive surgery (MIS), complex spine, deformity and degenerative procedures. Expertise in both orthobiologic sciences and spinal fusion hardware product development helps SeaSpine to offer its surgeon customers a complete solution to meet their fusion requirements. SeaSpine currently markets its products in the United States and in over 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 features and potential benefits of OsteoBallast DBM in Resorbable Mesh, including its ability to provide surgeons a simple means for delivering bone graft in posterior spine surgeries and help prevent graft migration during posterolateral fusion, as well as contour to local anatomy and maintain shape and volume under compression; and the timing of limited and full commercial launches of OsteoBallast DBM in Resorbable Mesh.  Among the factors that could cause or contribute to material differences between our actual results and the expectations indicated by our forward-looking statements are risks and uncertainties that include, but are not limited to: the fact that OsteoBallast DBM in Resorbable Mesh has not been validated clinically, may not address adequately surgeon requirements, and may require substantial additional development activities, which could introduce unexpected expense and delay, including potentially requiring resubmission of one or more products to FDA for clearance, which clearance cannot be certain, whether on a timely basis or at all; surgeons’ willingness to use OsteoBallast DBM in Resorbable Mesh; the risk that OsteoBallast DBM in Resorbable Mesh may not demonstrate adequate safety or efficacy, including improved fusion, independently or relative to competitive products, to support a full commercial launch; the risk of supply shortages, including as a result of our dependence on a limited number of third-party suppliers for components and raw materials, or otherwise; and other risks and uncertainties more fully described in our 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
Lynn Pieper
(415) 937-5402
[email protected]