{"id":399772,"date":"2020-12-15T08:03:39","date_gmt":"2020-12-15T13:03:39","guid":{"rendered":"http:\/\/www.marketnewsdesk.com\/?p=399772"},"modified":"2020-12-15T08:03:39","modified_gmt":"2020-12-15T13:03:39","slug":"seaspine-announces-fda-510k-clearance-for-amended-indication-for-nanometalene-surface-technology","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/seaspine-announces-fda-510k-clearance-for-amended-indication-for-nanometalene-surface-technology\/","title":{"rendered":"SeaSpine Announces FDA 510(k) Clearance for Amended Indication for NanoMetalene\u00ae Surface Technology"},"content":{"rendered":"<div class=\"mw_release\">\n<p>CARLSBAD, Calif., Dec.  15, 2020  (GLOBE NEWSWIRE) &#8212; 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\u00ae surface technology with amended indications.<\/p>\n<p>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.<\/p>\n<p>The new 510(k) clearance allows SeaSpine to describe NanoMetalene surface technology as \u201cproviding a microscopic roughened surface with nano-scale features\u201d 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.<\/p>\n<p>\u201cOur innovative NanoMetalene surface technology continues to be a key differentiator in the marketplace,\u201d stated Keith C. Valentine, President and Chief Executive Officer. \u201cFoundational to our Fusion Engineered\u2122 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.\u201d<sup>1,2<\/sup><\/p>\n<p>\u201cSeaSpine\u2019s commitment to advancing the development of differentiated surface materials with clinically relevant design features is highlighted by the recent introductions of Reef Topography\u2122 and WaveForm\u2122 3D-printed technology,\u201d said Mike Hall, Senior Director, Marketing. \u201cThe 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.\u201d<\/p>\n<ol>\n<li>NanoMetalene SEM images on file. TR-0094-19-01<\/li>\n<li>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<\/li>\n<\/ol>\n<p>\n        <strong>About SeaSpine<\/strong><br \/>\n        <br \/>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\u2019s 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\u2019s 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.<\/p>\n<p>\n        <strong>Forward-Looking Statements<\/strong><br \/>\n        <br \/>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\u2019s 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\u2019s commitment to advancing the development of differentiated surface materials with clinically relevant design features; and whether the Company\u2019s 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\u2019s actual results and the expectations indicated by the forward-looking statements are risks and uncertainties that include, but are not limited to: the Company\u2019s 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\u2019 willingness to continue to use the Company\u2019s 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 \u201calpha\u201d) 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\u2019s news releases and periodic filings with the Securities and Exchange Commission. The Company\u2019s public filings with the Securities and Exchange Commission are available at www.sec.gov.<\/p>\n<p>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.<\/p>\n<p>\n        <strong>Investor Relations Contact <\/strong><br \/>\n        <br \/>Leigh Salvo<br \/>(415) 937-5402<br \/><u><a href=\"https:\/\/www.globenewswire.com\/Tracker?data=gLXAJN6R9Mr6vT5024KxVOxxFu-LrLrKuZjENF1WV16u0d12-Svkz8Fgp_L18BwunetuBFmBxYPqbbOQ7gEpVA==\" rel=\"nofollow noopener noreferrer\" target=\"_blank\">ir@seaspine.com<\/a><\/u><\/p>\n<p>      <img loading=\"lazy\" decoding=\"async\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODExMjE1MSMzODgxMjY4IzIwMTg3Nzc=\" width=\"1\" height=\"1\" \/><br \/>\n      <br \/>\n      <img loading=\"lazy\" decoding=\"async\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/ml.globenewswire.com\/release\/track\/d6e21f7f-d278-4ac1-bdf5-4767bf2a11dc\" width=\"1\" height=\"1\" \/>\n    <\/div>\n<div class=\"mw_contactinfo\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>CARLSBAD, Calif., Dec. 15, 2020 (GLOBE NEWSWIRE) &#8212; 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\u00ae 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 &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/seaspine-announces-fda-510k-clearance-for-amended-indication-for-nanometalene-surface-technology\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;SeaSpine Announces FDA 510(k) Clearance for Amended Indication for NanoMetalene\u00ae Surface Technology&#8221;<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-399772","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>SeaSpine Announces FDA 510(k) Clearance for Amended Indication for NanoMetalene\u00ae Surface Technology - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/seaspine-announces-fda-510k-clearance-for-amended-indication-for-nanometalene-surface-technology\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"SeaSpine Announces FDA 510(k) Clearance for Amended Indication for NanoMetalene\u00ae Surface Technology - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"CARLSBAD, Calif., Dec. 15, 2020 (GLOBE NEWSWIRE) &#8212; 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\u00ae 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 &hellip; Continue reading &quot;SeaSpine Announces FDA 510(k) Clearance for Amended Indication for NanoMetalene\u00ae Surface Technology&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/seaspine-announces-fda-510k-clearance-for-amended-indication-for-nanometalene-surface-technology\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2020-12-15T13:03:39+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODExMjE1MSMzODgxMjY4IzIwMTg3Nzc=\" \/>\n<meta name=\"author\" content=\"Newsdesk\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Newsdesk\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"5 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/seaspine-announces-fda-510k-clearance-for-amended-indication-for-nanometalene-surface-technology\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/seaspine-announces-fda-510k-clearance-for-amended-indication-for-nanometalene-surface-technology\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"SeaSpine Announces FDA 510(k) Clearance for Amended Indication for NanoMetalene\u00ae Surface Technology\",\"datePublished\":\"2020-12-15T13:03:39+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/seaspine-announces-fda-510k-clearance-for-amended-indication-for-nanometalene-surface-technology\\\/\"},\"wordCount\":929,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/seaspine-announces-fda-510k-clearance-for-amended-indication-for-nanometalene-surface-technology\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.globenewswire.com\\\/newsroom\\\/ti?nf=ODExMjE1MSMzODgxMjY4IzIwMTg3Nzc=\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/seaspine-announces-fda-510k-clearance-for-amended-indication-for-nanometalene-surface-technology\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/seaspine-announces-fda-510k-clearance-for-amended-indication-for-nanometalene-surface-technology\\\/\",\"name\":\"SeaSpine Announces FDA 510(k) Clearance for Amended Indication for NanoMetalene\u00ae Surface Technology - 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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 &hellip; Continue reading \"SeaSpine Announces FDA 510(k) Clearance for Amended Indication for NanoMetalene\u00ae Surface Technology\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/seaspine-announces-fda-510k-clearance-for-amended-indication-for-nanometalene-surface-technology\/","og_site_name":"Market Newsdesk","article_published_time":"2020-12-15T13:03:39+00:00","og_image":[{"url":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODExMjE1MSMzODgxMjY4IzIwMTg3Nzc=","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"5 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/seaspine-announces-fda-510k-clearance-for-amended-indication-for-nanometalene-surface-technology\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/seaspine-announces-fda-510k-clearance-for-amended-indication-for-nanometalene-surface-technology\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"SeaSpine Announces FDA 510(k) Clearance for Amended Indication for NanoMetalene\u00ae Surface Technology","datePublished":"2020-12-15T13:03:39+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/seaspine-announces-fda-510k-clearance-for-amended-indication-for-nanometalene-surface-technology\/"},"wordCount":929,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/seaspine-announces-fda-510k-clearance-for-amended-indication-for-nanometalene-surface-technology\/#primaryimage"},"thumbnailUrl":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODExMjE1MSMzODgxMjY4IzIwMTg3Nzc=","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/seaspine-announces-fda-510k-clearance-for-amended-indication-for-nanometalene-surface-technology\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/seaspine-announces-fda-510k-clearance-for-amended-indication-for-nanometalene-surface-technology\/","name":"SeaSpine Announces FDA 510(k) Clearance for Amended Indication for NanoMetalene\u00ae Surface Technology - 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