{"id":464929,"date":"2021-03-25T07:33:10","date_gmt":"2021-03-25T11:33:10","guid":{"rendered":"http:\/\/www.marketnewsdesk.com\/?p=464929"},"modified":"2021-03-25T07:33:10","modified_gmt":"2021-03-25T11:33:10","slug":"aurora-spine-receives-fda-510k-clearance-for-its-proprietary-apollo-anterior-cervical-plate","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/aurora-spine-receives-fda-510k-clearance-for-its-proprietary-apollo-anterior-cervical-plate\/","title":{"rendered":"Aurora Spine Receives FDA 510(K) Clearance for Its Proprietary APOLLO Anterior Cervical Plate"},"content":{"rendered":"<div class=\"mw_release\">\n<p align=\"justify\">CARLSBAD, Calif., March  25, 2021  (GLOBE NEWSWIRE) &#8212; Aurora Spine Corporation (\u201cAurora Spine\u201d or the \u201cCompany\u201d) (TSXV: ASG) (OTCQB: ASAPF), a designer and manufacturer of innovative medical devices that improve spinal surgery outcomes, announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its proprietary APOLLO Anterior Cervical Plate (ACP) system, featuring a sleek 1.9mm design, with Hyper-Angulation\u2122 variability in the Cephalad-Caudal screw angulation of 32\u00b0 &#8211; Freedom to Angulate\u2122.<\/p>\n<p align=\"justify\">The new ACP system challenges the status quo of cervical spine technology. It is designed to help reduce common postoperative complications, such as dysphagia, malalignment, and adjacent level ossification, by enabling surgeons to customize treatment to patient needs versus a traditional one-size-fits-all approach, and consists of:<\/p>\n<ul type=\"disc\">\n<li style=\"margin-top:5pt;margin-bottom:5pt;text-align:justify\">\n          <strong>Freedom to Angulate<\/strong>, including Hyper-Angulation\u2122 screw variability, to optimized performance for each surgical level to support construct stability.<\/li>\n<li style=\"margin-top:5pt;margin-bottom:5pt;text-align:justify\">\n          <strong>A wide array of implant length options\u00a0<\/strong>to match a variety of patient anatomies and to facilitate maximizing the distance from the adjacent levels; and<\/li>\n<li style=\"margin-top:5pt;margin-bottom:5pt;text-align:justify\">\n          <strong>A range of advanced screw offerings<\/strong>\u00a0with fixed and variable angles to enable better screw placement and locking accuracy.<\/li>\n<li style=\"margin-top:5pt;margin-bottom:5pt;text-align:justify\">\n          <strong>APOLLO\u2122 is part the DEXA\u2122 family of products:<\/strong>\u00a0positioned to reshape the market through patent focused innovation and address the next advancement in spine surgery \u2013 DEXA Interbody Technology.<\/li>\n<\/ul>\n<p align=\"justify\">\u201cThere are an estimated 180,000 cervical fusion procedures performed in the United States each year to relieve compression on the spinal cord or nerve roots. Receiving FDA 510(k) clearance for the APOLLO\u2122 (ACP) system reflects Aurora Spine\u2019s commitment to deliver innovative, modern technology for the anterior cervical spine and to support positive clinical outcomes,\u201d said Trent Northcutt, President and CEO, at Aurora Spine. \u201cThe launch of APOLLO\u2122 (ACP) is key to our long-term cervical implant strategy and represents a significant opportunity for growth, as cervical spine procedures comprise an approximately $2.6 billion segment of the global spine market.\u201d<\/p>\n<p align=\"justify\">Mr. Northcutt added, \u201cThis approval is an important piece to the puzzle for advancing Aurora Spine\u2019s key initiative of bringing more proprietary-based products to the marketplace and decreasing our reliance on third-party products. Sales of cervical plates in fiscal 2019 represented approximately 10% of revenues for Aurora and the APOLLO plate will enable Aurora to convert another portion of the company\u2019s revenue base into a proprietary product and allow us to capture higher margins. This new product will also support sales of our TiNANO\u2122 cervical cages and enable us to develop additional products around our DEXA\u2122 patent, which matches implants to a patient\u2019s bone density. This approval is a great step for Aurora in fiscal 2021 and we are hopeful to deliver several new key products throughout the year.\u201d<\/p>\n<p align=\"justify\">\n        <strong>About Aurora Spine<\/strong>\n      <\/p>\n<p align=\"justify\">Aurora Spine is focused on bringing new solutions to the spinal implant and pain management markets through a series of innovative, minimally invasive, regenerative spinal implant technologies. Additional information can be accessed at <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=7er3C4aw_xyezisecNntRaNj4-irbpKT7TOtMqqPBYCpIje9ejMEsGYqwX7pqOeBTMytZnl1wh2KZvEh-D4xR9ybj2cpz32-UAjmkXorh4M=\" rel=\"nofollow noopener noreferrer\" target=\"_blank\">www.aurora-spine.com<\/a> or <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=7er3C4aw_xyezisecNntRayX5WQfCsGc70QYrP1_0JGU9tDI63bgDx4aGZcM5ROlpG6taR2ujjai4va5Ju_b8V1mBbAZ0oR216iLElsp50g=\" rel=\"nofollow noopener noreferrer\" target=\"_blank\">www.aurorapaincare.com<\/a>.<\/p>\n<p align=\"justify\">Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.<\/p>\n<p align=\"justify\">\n        <strong>Forward-Looking Statements<\/strong>\n      <\/p>\n<p align=\"justify\">This news release contains forward-looking information that involves substantial known and unknown risks and uncertainties, most of which are beyond the control of Aurora Spine, including, without limitation, those listed under &#8220;Risk Factors&#8221; and &#8220;Cautionary Statement Regarding Forward-Looking Information&#8221; in Aurora Spine&#8217;s final prospectus (collectively, &#8220;forward-looking information&#8221;). Forward-looking information in this news release includes information concerning the proposed use and success of the company\u2019s products in surgical procedures. Aurora Spine cautions investors of Aurora Spine&#8217;s securities about important factors that could cause Aurora Spine&#8217;s actual results to differ materially from those projected in any forward-looking statements included in this news release. Any statements that express, or involve discussions as to, expectations, beliefs, plans, objectives, assumptions or future events or performance are not historical facts and may be forward-looking and may involve estimates, assumptions and uncertainties which could cause actual results or outcomes to differ unilaterally from those expressed in such forward-looking statements. No assurance can be given that the expectations set out herein will prove to be correct and, accordingly, prospective investors should not place undue reliance on these forward-looking statements. These statements speak only as of the date of this press release and Aurora Spine does not assume any obligation to update or revise them to reflect new events or circumstances.<\/p>\n<p align=\"justify\">\n        <strong>Contact<\/strong>:<\/p>\n<p align=\"justify\">Aurora Spine Corporation<\/p>\n<p align=\"justify\">Trent Northcutt<br \/>President and Chief Executive Officer<br \/>(760) 424-2004<\/p>\n<p align=\"justify\">Chad Clouse<br \/>Chief Financial Officer<br \/>(760) 424-2004<br \/><a href=\"https:\/\/www.globenewswire.com\/Tracker?data=7er3C4aw_xyezisecNntRUE-e7ygH5alURax3URWvwODk6sfgJ7FcOaA0KQ6xfp1E-1w2caYtPlsdUQQqVjBs39XNl0VpbHybVJBdfrfz20=\" rel=\"nofollow noopener noreferrer\" target=\"_blank\">www.aurora-spine.com<\/a><br \/><a href=\"https:\/\/www.globenewswire.com\/Tracker?data=7er3C4aw_xyezisecNntRayX5WQfCsGc70QYrP1_0JGnEG0qtI3PyLnGCTted5dBqX5n2zcJtxOgvPyO7sU2jSZszT4d54kxygtCrywPaT8=\" rel=\"nofollow noopener noreferrer\" target=\"_blank\">www.aurorapaincare.com<\/a><\/p>\n<p align=\"justify\">Adam Lowensteiner <br \/>LYTHAM PARTNERS, LLC<br \/>Phoenix | New York<br \/>Telephone: 646-829-9700<br \/><a href=\"https:\/\/www.globenewswire.com\/Tracker?data=v58DKdLMc07PV_YztCpv2-hjp14zbCdLEmeeo3KrESiIGvvnW5I-f2mRCSBIPx8KTuq69ivyawkiZdhAEZoLFhIIFz3OqT8FRh8sU9r_kOc=\" rel=\"nofollow noopener noreferrer\" target=\"_blank\">arosf@lythampartners.com<\/a><\/p>\n<p \/>\n      <img loading=\"lazy\" decoding=\"async\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODIwNjIyOSM0MDkxMjE1IzIwMjgwNTc=\" width=\"1\" height=\"1\" \/><br \/>\n      <br \/>\n      <img loading=\"lazy\" decoding=\"async\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/ml.globenewswire.com\/release\/track\/43e79153-1434-4b04-b773-ec5494f87f30\" width=\"1\" height=\"1\" \/>\n    <\/div>\n<div class=\"mw_contactinfo\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>CARLSBAD, Calif., March 25, 2021 (GLOBE NEWSWIRE) &#8212; Aurora Spine Corporation (\u201cAurora Spine\u201d or the \u201cCompany\u201d) (TSXV: ASG) (OTCQB: ASAPF), a designer and manufacturer of innovative medical devices that improve spinal surgery outcomes, announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its proprietary APOLLO Anterior Cervical Plate (ACP) system, featuring a sleek 1.9mm design, with Hyper-Angulation\u2122 variability in the Cephalad-Caudal screw angulation of 32\u00b0 &#8211; Freedom to Angulate\u2122. The new ACP system challenges the status quo of cervical spine technology. It is designed to help reduce common postoperative complications, such as dysphagia, malalignment, and adjacent level ossification, by enabling surgeons to customize treatment to patient needs versus a traditional one-size-fits-all approach, and consists &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/aurora-spine-receives-fda-510k-clearance-for-its-proprietary-apollo-anterior-cervical-plate\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Aurora Spine Receives FDA 510(K) Clearance for Its Proprietary APOLLO Anterior Cervical Plate&#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-464929","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Aurora Spine Receives FDA 510(K) Clearance for Its Proprietary APOLLO Anterior Cervical Plate - 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\/aurora-spine-receives-fda-510k-clearance-for-its-proprietary-apollo-anterior-cervical-plate\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Aurora Spine Receives FDA 510(K) Clearance for Its Proprietary APOLLO Anterior Cervical Plate - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"CARLSBAD, Calif., March 25, 2021 (GLOBE NEWSWIRE) &#8212; Aurora Spine Corporation (\u201cAurora Spine\u201d or the \u201cCompany\u201d) (TSXV: ASG) (OTCQB: ASAPF), a designer and manufacturer of innovative medical devices that improve spinal surgery outcomes, announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its proprietary APOLLO Anterior Cervical Plate (ACP) system, featuring a sleek 1.9mm design, with Hyper-Angulation\u2122 variability in the Cephalad-Caudal screw angulation of 32\u00b0 &#8211; Freedom to Angulate\u2122. The new ACP system challenges the status quo of cervical spine technology. It is designed to help reduce common postoperative complications, such as dysphagia, malalignment, and adjacent level ossification, by enabling surgeons to customize treatment to patient needs versus a traditional one-size-fits-all approach, and consists &hellip; Continue reading &quot;Aurora Spine Receives FDA 510(K) Clearance for Its Proprietary APOLLO Anterior Cervical Plate&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/aurora-spine-receives-fda-510k-clearance-for-its-proprietary-apollo-anterior-cervical-plate\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2021-03-25T11:33:10+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODIwNjIyOSM0MDkxMjE1IzIwMjgwNTc=\" \/>\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=\"4 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\\\/aurora-spine-receives-fda-510k-clearance-for-its-proprietary-apollo-anterior-cervical-plate\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/aurora-spine-receives-fda-510k-clearance-for-its-proprietary-apollo-anterior-cervical-plate\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"Aurora Spine Receives FDA 510(K) Clearance for Its Proprietary APOLLO Anterior Cervical Plate\",\"datePublished\":\"2021-03-25T11:33:10+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/aurora-spine-receives-fda-510k-clearance-for-its-proprietary-apollo-anterior-cervical-plate\\\/\"},\"wordCount\":772,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/aurora-spine-receives-fda-510k-clearance-for-its-proprietary-apollo-anterior-cervical-plate\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.globenewswire.com\\\/newsroom\\\/ti?nf=ODIwNjIyOSM0MDkxMjE1IzIwMjgwNTc=\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/aurora-spine-receives-fda-510k-clearance-for-its-proprietary-apollo-anterior-cervical-plate\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/aurora-spine-receives-fda-510k-clearance-for-its-proprietary-apollo-anterior-cervical-plate\\\/\",\"name\":\"Aurora Spine Receives FDA 510(K) Clearance for Its Proprietary APOLLO Anterior Cervical Plate - 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Market Newsdesk","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.marketnewsdesk.com\/index.php\/aurora-spine-receives-fda-510k-clearance-for-its-proprietary-apollo-anterior-cervical-plate\/","og_locale":"en_US","og_type":"article","og_title":"Aurora Spine Receives FDA 510(K) Clearance for Its Proprietary APOLLO Anterior Cervical Plate - Market Newsdesk","og_description":"CARLSBAD, Calif., March 25, 2021 (GLOBE NEWSWIRE) &#8212; Aurora Spine Corporation (\u201cAurora Spine\u201d or the \u201cCompany\u201d) (TSXV: ASG) (OTCQB: ASAPF), a designer and manufacturer of innovative medical devices that improve spinal surgery outcomes, announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its proprietary APOLLO Anterior Cervical Plate (ACP) system, featuring a sleek 1.9mm design, with Hyper-Angulation\u2122 variability in the Cephalad-Caudal screw angulation of 32\u00b0 &#8211; Freedom to Angulate\u2122. The new ACP system challenges the status quo of cervical spine technology. It is designed to help reduce common postoperative complications, such as dysphagia, malalignment, and adjacent level ossification, by enabling surgeons to customize treatment to patient needs versus a traditional one-size-fits-all approach, and consists &hellip; Continue reading \"Aurora Spine Receives FDA 510(K) Clearance for Its Proprietary APOLLO Anterior Cervical Plate\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/aurora-spine-receives-fda-510k-clearance-for-its-proprietary-apollo-anterior-cervical-plate\/","og_site_name":"Market Newsdesk","article_published_time":"2021-03-25T11:33:10+00:00","og_image":[{"url":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODIwNjIyOSM0MDkxMjE1IzIwMjgwNTc=","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"4 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/aurora-spine-receives-fda-510k-clearance-for-its-proprietary-apollo-anterior-cervical-plate\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/aurora-spine-receives-fda-510k-clearance-for-its-proprietary-apollo-anterior-cervical-plate\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"Aurora Spine Receives FDA 510(K) Clearance for Its Proprietary APOLLO Anterior Cervical Plate","datePublished":"2021-03-25T11:33:10+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/aurora-spine-receives-fda-510k-clearance-for-its-proprietary-apollo-anterior-cervical-plate\/"},"wordCount":772,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/aurora-spine-receives-fda-510k-clearance-for-its-proprietary-apollo-anterior-cervical-plate\/#primaryimage"},"thumbnailUrl":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODIwNjIyOSM0MDkxMjE1IzIwMjgwNTc=","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/aurora-spine-receives-fda-510k-clearance-for-its-proprietary-apollo-anterior-cervical-plate\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/aurora-spine-receives-fda-510k-clearance-for-its-proprietary-apollo-anterior-cervical-plate\/","name":"Aurora Spine Receives FDA 510(K) Clearance for Its Proprietary APOLLO Anterior Cervical Plate - 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