SeaSpine® Announces FDA 510(k) Clearance for Amended Indication for NanoMetalene® Surface Technology
CARLSBAD, Calif., Dec. 15, 2020 (GLOBE NEWSWIRE) — 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 U.S. Food and Drug Administration (FDA) to market its NanoMetalene® surface technology with amended indications.
NanoMetalene describes a surface technology for interbody devices that incorporates a submicron layer of commercially pure titanium molecularly bonded to a PEEK implant using a high-energy, low-temperature process. NanoMetalene is designed to provide a molecularly bonded layer of bone-friendly titanium on the entire surface area of the implant, including endplates and throughout graft apertures, while retaining the benefits associated with traditional PEEK implants, such as biocompatibility, a modulus of elasticity similar to bone, and excellent radiographic visibility for postoperative imaging.
The new 510(k) clearance allows SeaSpine to describe NanoMetalene surface technology as "providing a microscopic roughened surface with nano-scale features" and amends indications for use across the 12 implant systems to which NanoMetalene previously has been applied. SeaSpine intends to incorporate NanoMetalene with additional implant systems over the next year.
"Our innovative NanoMetalene surface technology continues to be a key differentiator in the marketplace," stated Keith C. Valentine, President and Chief Executive Officer. "Foundational to our Fusion Engineered™ philosophy, these amended indications give us the opportunity to further educate surgeons about the benefits of NanoMetalene, including how its rough micro- and nano-scale topography is designed to encourage integration."1,2
"SeaSpine's commitment to advancing the development of differentiated surface materials with clinically relevant design features is highlighted by the recent introductions of Reef Topography™ and WaveForm™ 3D-printed technology," said Mike Hall, Senior Director, Marketing. "The success of NanoMetalene, with more than 35,000 devices implanted to date, demonstrates that our focus on science and data allows us to deliver implants deliberately designed to facilitate the best fusion results for patients."
NanoMetalene SEM images on file. TR-0094-19-01
Walsh, et al. The in vivo response to a novel Ti coating compared with polyether ether ketone: evaluation of the periphery and inner surfaces of an implant. Spine Journal 2018 Jul; 18(7): 1231-1240
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 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 both orthobiologic sciences and spinal implants 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 objectives of product design and the ability of the underlying products to achieve design objectives; intentions to incorporate NanoMetalene with additional systems; the ability for the Company to further educate surgeons about the benefits of NanoMetalene; the Company's commitment to advancing the development of differentiated surface materials with clinically relevant design features; and whether the Company's focus on science and data allows it to deliver implants designed to facilitate fusion results for patients. 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 Company's ability to successfully develop new products and the costs associated with designing and developing those new products, including risks inherent in the use of novel manufacturing techniques, including additive processing/3D printing; surgeons' willingness to continue to use the Company's NanoMetalene products; the ability of newly launched products to perform as designed and intended and to meet the needs of surgeons and patients, including as a result of the lack of clinical validation of products in limited commercial (or "alpha") launch; unexpected delays, including as a result of developing and supporting the launch of new products, including the fact that newly launched products may require substantial additional development activities, which could introduce further delay, 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.
Leigh Salvo
ir@seaspine.com
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