{"id":12744,"date":"2017-03-15T09:34:33","date_gmt":"2017-03-15T13:34:33","guid":{"rendered":"http:\/\/bioventuspub.wpengine.com\/bones\/"},"modified":"2017-03-15T09:34:33","modified_gmt":"2017-03-15T13:34:33","slug":"bones","status":"publish","type":"post","link":"https:\/\/www.bioventus.com\/es\/bones\/","title":{"rendered":"Bioventus to Invest in New Clinical Research  for EXOGEN"},"content":{"rendered":"<p><strong>DURHAM, NC \u2013 March 15, 2017 \u2013 <\/strong><a href=\"https:\/\/new.bioventusglobal.com\">Bioventus<\/a>, a global leader in orthobiologics, today announced it will commission an innovative series of real-world evidence, direct-to-patient studies to further validate the ability of its <strong>EXOGEN Ultrasound Bone Healing System<\/strong> to mitigate the risk of a fracture progressing to nonunion in the presence of known risk factors. FDA PMA approved in 1994, <strong>EXOGEN <\/strong>has provided treatment to more than 1 million patients worldwide for more than 20 years and has a long clinical history. The product uses safe, effective low-intensity pulsed ultrasound (LIPUS) to help stimulate the body\u2019s natural healing\u00a0process.<sup>1<\/sup><\/p>\n<p>Recent publications analyzing data from a large registry of almost 8,000 fractures treated with <strong>EXOGEN<\/strong> suggest that the device supports healing fractures in patients despite the presence of associated comorbidities or medication use.<sup>2,3,4<\/sup> \u00a0This new clinical research, known as the Bioventus Observational Non-interventional EXOGEN Studies (BONES), will build on this evidence and supplement the product\u2019s broad body of clinical knowledge in a prospective population-based innovative clinical development program.<\/p>\n<p>The BONES studies will compare the incidence of fracture nonunions in patients utilizing the <strong>EXOGEN<\/strong> device with patients from a national health insurance claims database who received standard of care alone. The studies will include bones representative of long and small bones of upper and lower extremities. The unique design was discussed with FDA during its development.<\/p>\n<p>\u201cBONES represents a significant investment in developing epidemiologically grounded rigorous clinical evidence to support use of <strong>EXOGEN <\/strong>in fractures at risk, and to underscore the product\u2019s clinical utility in mitigating the risk of nonunions, a highly debilitating and costly condition,\u201d said Alessandra Pavesio, Senior Vice President and Chief Science Officer, Bioventus. \u201cIt will build upon knowledge gained from extensive research conducted by Bioventus and recently published in <em>JAMA Surgery<\/em>, in over 700,000 fracture patients that has identified 40-plus factors which place a patient at an increased risk of progression to a nonunion.<sup>5<\/sup>\u201d<\/p>\n<p><strong>About Bioventus<\/strong><\/p>\n<p>Bioventus is an orthobiologics company that delivers clinically proven, cost-effective products that help people heal quickly and safely. Its mission is to make a difference by helping patients resume and enjoy active lives. Bioventus has two product portfolios for orthobiologics, Bioventus Active Healing Therapies and Bioventus Surgical that make it a global leader in active orthopaedic healing. Its <a href=\"http:\/\/www.exogen.com\">EXOGEN<sup>\u00ae<\/sup> Ultrasound Bone Healing System<\/a> is the #1 prescribed bone healing system in the US and is the only FDA-approved bone healing device that uses safe, effective ultrasound to stimulate the body\u2019s natural healing process. Built on a commitment to high quality standards, evidence-based medicine and strong ethical behavior, Bioventus is a trusted partner for physicians worldwide.<\/p>\n<p>For more information, visit <a href=\"https:\/\/new.bioventusglobal.com\">www.BioventusGlobal.com<\/a> and follow the company on Twitter <a href=\"https:\/\/twitter.com\/BioventusGlobal\">@Bioventusglobal.<\/a><\/p>\n<p><strong>Media Contact:\u00a0<\/strong>Thomas Hill, +1 &nbsp;, <a href=\"mailto:thomas.hill@bioventusglobal.com\">thomas.hill@bioventusglobal.com<\/a><\/p>\n<p>Bioventus, the Bioventus logo, and EXOGEN are registered trademarks of Bioventus LLC.<\/p>\n<ol>\n<li>Azuma Y, Ito M, Harada Y, Takagi H, Ohta T, Jingushi S. Low-intensity pulsed ultrasound accelerates rat femoral fracture healing by acting on the various cellular reactions in the fracture callus.<em>J Bone Miner Res<\/em>. 2001; 16(4):671-680.<\/li>\n<li>Nolte P, Anderson R, Strauss E, Hu L, J Jones, RG Steen.\u00a0 2016.\u00a0 Heal rate of metatarsal fractures: A propensity-matching study of low-intensity pulsed ultrasound (LIPUS) vs. surgical and other treatments.\u00a0 <em>Injury<\/em>. 2017 47(11):2584-2590.<\/li>\n<li>Zura R, G Della Rocca, S Mehta, A Harrison, C Brodie, J Jones, RG <strong>Steen<\/strong>.\u00a0 2015.\u00a0 Treatment of chronic (&gt; 1 year) fracture nonunion: Heal rate in a cohort of 767 patients treated with low-intensity pulsed ultrasound (LIPUS). <em>Injury<\/em> 46:2036-2041.<\/li>\n<li>Zura R, S Mehta, G Della Rocca, J Jones, RG Steen.\u00a0 2015.\u00a0 A cohort study of 4,190 patients treated with low-intensity pulsed ultrasound (LIPUS): Findings in the elderly versus all patients.\u00a0 <em>BMC Musculoskel. Dis<\/em><u>.<\/u> 16:45.<\/li>\n<li>Zura R, Xiong Z, Einhorn T, Watson JT, Ostrum RF, Prayson MJ, Della Rocca GJ, Mehta S, McKinley T, Wang Z, Steen RG. Epidemiology of Fracture Nonunion in 18 Human Bones, <em>JAMA Surger<\/em> 2016: e162775. doi:10.1001\/jamasurg.2016.2775.<\/li>\n<\/ol>\n<p><strong>EXOGEN &#8211; Summary of Indications for Use in the US<\/strong><\/p>\n<p>*Summary of Indications for Use: The EXOGEN Ultrasound Bone Healing System is indicated for the non-invasive treatment of established non-unions* excluding skull and vertebra. In addition, EXOGEN is indicated for accelerating the time to a healed fracture for fresh, closed, posteriorly displaced distal radius fractures and fresh, closed or Grade I open tibial diaphysis fractures in skeletally mature individuals when these fractures are orthopaedically managed by closed reduction and cast immobilization. There are no known contraindications for the EXOGEN device. Safety and effectiveness has not been established for individuals lacking skeletal maturity; pregnant or nursing women; patients with cardiac pacemakers; on fractures due to bone cancer; or on patients with poor blood circulation or clotting problems. Some patients may be sensitive to the ultrasound gel. Full prescribing information can be found in product labeling, at www.exogen.com or by contacting customer service at 1-800-836-4080. *A nonunion is considered to be established when the fracture site shows no visibly progressive signs of healing.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>DURHAM, NC \u2013 March 15, 2017 \u2013 Bioventus, a global leader in orthobiologics, today announced it will commission an innovative [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-12744","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Bioventus to Invest in New Clinical Research for EXOGEN - Bioventus<\/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.bioventus.com\/es\/bones\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Bioventus to Invest in New Clinical Research for EXOGEN - 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