{"id":4841,"date":"2025-11-05T05:57:59","date_gmt":"2025-11-05T13:57:59","guid":{"rendered":"https:\/\/www.fziomed.com\/usa\/?p=4841"},"modified":"2025-11-05T05:57:59","modified_gmt":"2025-11-05T13:57:59","slug":"fziomed-gains-fda-de-novo-classification-grant-and-marketing-authorization-for-oxiplex-gel-in-spine-surgery-2","status":"publish","type":"post","link":"https:\/\/www.fziomed.com\/usa\/fziomed-gains-fda-de-novo-classification-grant-and-marketing-authorization-for-oxiplex-gel-in-spine-surgery-2\/","title":{"rendered":"Fziomed Initiates Commercialization of Oxiplex Gel in the United States"},"content":{"rendered":"\n<p><em><em>Best-in-class, synthetic, absorbable gel for use as an adjunct in lumbar spine surgery for the reduction of leg pain and neurological symptoms now available in the United States.<\/em><\/em><\/p>\n\n\n\n<p><\/p>\n\n\n<p style=\"font-weight: 400\"><strong>SAN LUIS OBISPO, California, Nov. 5, 2025 \u2014 Fziomed, Inc.<\/strong> (\u201cFziomed\u201d or the \u201cCompany\u201d), a recognized global leader in postsurgical adhesion prevention with the best-in-class synthetic, absorbable gel technology platform, today announced that the Company has initiated commercialization of Oxiplex<sup>\u00ae<\/sup> gel in the United States, indicated for reducing postoperative leg pain and neurological symptoms in adult patients undergoing lumbar spine procedures. Oxiplex is the first and only FDA authorized intraoperative gel specifically designed for this indication.<\/p>\n<p style=\"font-weight: 400\">\u201cWe are proud to introduce Oxiplex in the United States, marking an important step in expanding patient access to our proven dual-polymer technology,\u201d said Ryan Bledsoe, Vice President of Marketing and Market Access at Fziomed. \u201cThis milestone reflects our unwavering commitment to support surgeons with innovative solutions that improve patient outcomes and advance surgical care.\u201d<\/p>\n<p style=\"font-weight: 400\">\u201cHaving Oxiplex available in the U.S. provides spine surgeons with a new, evidence-based tool to address a significant unmet clinical need,\u201d said Alfred L. Rhyne, MD, orthopedic surgeon specializing in the diagnosis and treatment of spine conditions at OrthoCarolina (Charlotte, NC). \u201cPatients will now benefit from a technology that has been validated in rigorous clinical studies and used successfully in hundreds of thousands of procedures worldwide.\u201d<\/p>\n<p style=\"font-weight: 400\">Fziomed\u2019s Oxiplex is a safe, easy-to-use, absorbable, clear gel applied directly to nerves and surrounding tissues during surgery immediately prior to closure. In spine surgery, Oxiplex acts as a temporary physical barrier between adjacent tissues and has been shown in multiple peer-reviewed publications to reduce postoperative leg pain and neurological symptoms. Oxiplex gel has been available outside the United States since 2002 and has been used in more than 750,000 spine procedures worldwide for postoperative adhesion prevention.<\/p>\n<p style=\"font-weight: 400\">Fziomed will attend the North American Spine Society (NASS) 40<sup>th<\/sup> Annual Meeting November 14-16, 2025, in Denver, Colorado, and will showcase its Oxiplex Absorbable Gel for Spine Surgery. Visit Fziomed at Booth #615 during NASS to learn more.<\/p>\n<p style=\"font-weight: 400\"><strong>About Fziomed, Inc.<\/strong><\/p>\n<p style=\"font-weight: 400\">Pioneering biomaterials since 1996, Fziomed is a recognized global leader in postsurgical adhesion prevention focused on addressing an unmet clinical need in spine, tendon, nerve, abdominal, pelvic, and intrauterine procedures. Fziomed develops, manufactures, and commercializes best-in-class surgical biomaterials used by clinicians to <em>Preserve Surgical Excellence<sup>SM<\/sup><\/em>and improve patient outcomes.<\/p>\n<p style=\"font-weight: 400\">Fziomed is headquartered in San Luis Obispo, California, and has been named one of the <em>Best Places to Work in Southern California<\/em> for the past three consecutive years.<\/p>\n<p style=\"font-weight: 400\">Visit <a href=\"http:\/\/www.fziomed.com\/\">fziomed.com<\/a> to learn more about Fziomed and our industry-leading products.<\/p>\n\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Best-in-class, synthetic, absorbable gel for use as an adjunct in lumbar spine surgery for the reduction of leg pain and neurological symptoms now available in the United States. SAN LUIS OBISPO, California, Nov. 5, 2025 \u2014 Fziomed, Inc. (\u201cFziomed\u201d or the \u201cCompany\u201d), a recognized global leader in postsurgical adhesion prevention with the best-in-class synthetic, absorbable [&hellip;]<\/p>\n","protected":false},"author":64,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"pmpro_default_level":"","footnotes":"","_links_to":"","_links_to_target":""},"categories":[44],"tags":[],"class_list":["post-4841","post","type-post","status-publish","format-standard","hentry","category-news-releases","pmpro-has-access"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Fziomed Initiates Commercialization of Oxiplex Gel in the United States - Fziomed USA<\/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.fziomed.com\/usa\/fziomed-gains-fda-de-novo-classification-grant-and-marketing-authorization-for-oxiplex-gel-in-spine-surgery-2\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Fziomed Initiates Commercialization of Oxiplex Gel in the United States - Fziomed USA\" \/>\n<meta property=\"og:description\" content=\"Best-in-class, synthetic, absorbable gel for use as an adjunct in lumbar spine surgery for the reduction of leg pain and neurological symptoms now available in the United States. 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