EXCLUSIVE: Vivani Medical Advances Its Obesity Treatment Implant With New Clinical Trial in Australia

Benzinga09-26

On Thursday, Vivani Medical, Inc. (NASDAQ:VANI) announced that the Bellberry Human Research Ethics Committee has approved, and the Therapeutic Goods Administration in Australia has formally ...

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(NASDAQ:VANI) announced that the Bellberry Human Research Ethics Committee has approved, and the Therapeutic Goods Administration in Australia has formally ...</p>\n\n<a href=\"https://finance.yahoo.com/news/exclusive-vivani-medical-advances-obesity-120037399.html\">Source Link</a>\n\n</div>\n","source":"yahoofinance","html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; charset=utf-8\" />\n<meta name=\"viewport\" content=\"width=device-width,initial-scale=1.0,minimum-scale=1.0,maximum-scale=1.0,user-scalable=no\"/>\n<meta name=\"format-detection\" content=\"telephone=no,email=no,address=no\" />\n<title>EXCLUSIVE: Vivani Medical Advances Its Obesity Treatment Implant With New Clinical Trial in Australia</title>\n<style type=\"text/css\">\na,abbr,acronym,address,applet,article,aside,audio,b,big,blockquote,body,canvas,caption,center,cite,code,dd,del,details,dfn,div,dl,dt,\nem,embed,fieldset,figcaption,figure,footer,form,h1,h2,h3,h4,h5,h6,header,hgroup,html,i,iframe,img,ins,kbd,label,legend,li,mark,menu,nav,\nobject,ol,output,p,pre,q,ruby,s,samp,section,small,span,strike,strong,sub,summary,sup,table,tbody,td,tfoot,th,thead,time,tr,tt,u,ul,var,video{ font:inherit;margin:0;padding:0;vertical-align:baseline;border:0 }\nbody{ font-size:16px; line-height:1.5; color:#999; background:transparent; }\n.wrapper{ overflow:hidden;word-break:break-all;padding:10px; }\nh1,h2{ font-weight:normal; line-height:1.35; margin-bottom:.6em; }\nh3,h4,h5,h6{ line-height:1.35; margin-bottom:1em; }\nh1{ font-size:24px; }\nh2{ font-size:20px; }\nh3{ font-size:18px; }\nh4{ font-size:16px; }\nh5{ font-size:14px; }\nh6{ font-size:12px; }\np,ul,ol,blockquote,dl,table{ margin:1.2em 0; }\nul,ol{ margin-left:2em; }\nul{ list-style:disc; }\nol{ list-style:decimal; }\nli,li p{ margin:10px 0;}\nimg{ max-width:100%;display:block;margin:0 auto 1em; }\nblockquote{ color:#B5B2B1; border-left:3px solid #aaa; padding:1em; }\nstrong,b{font-weight:bold;}\nem,i{font-style:italic;}\ntable{ width:100%;border-collapse:collapse;border-spacing:1px;margin:1em 0;font-size:.9em; }\nth,td{ padding:5px;text-align:left;border:1px solid #aaa; }\nth{ font-weight:bold;background:#5d5d5d; }\n.symbol-link{font-weight:bold;}\n/* header{ border-bottom:1px solid #494756; } */\n.title{ margin:0 0 8px;line-height:1.3;color:#ddd; }\n.meta {color:#5e5c6d;font-size:13px;margin:0 0 .5em; }\na{text-decoration:none; color:#2a4b87;}\n.meta .head { display: inline-block; overflow: hidden}\n.head .h-thumb { width: 30px; height: 30px; margin: 0; padding: 0; border-radius: 50%; float: left;}\n.head .h-content { margin: 0; padding: 0 0 0 9px; float: left;}\n.head .h-name {font-size: 13px; color: #eee; margin: 0;}\n.head .h-time {font-size: 11px; color: #7E829C; margin: 0;line-height: 11px;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\nEXCLUSIVE: Vivani Medical Advances Its Obesity Treatment Implant With New Clinical Trial in Australia\n</h2>\n\n<h4 class=\"meta\">\n\n\n2024-09-26 20:00 GMT+8&nbsp;&nbsp;&nbsp;<a href=https://finance.yahoo.com/news/exclusive-vivani-medical-advances-obesity-120037399.html><strong>Benzinga</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>On Thursday, Vivani Medical, Inc. (NASDAQ:VANI) announced that the Bellberry Human Research Ethics Committee has approved, and the Therapeutic Goods Administration in Australia has formally ...</p>\n\n<a href=\"https://finance.yahoo.com/news/exclusive-vivani-medical-advances-obesity-120037399.html\">Source Link</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"BK4082","symbol_name":"医疗保健设备","start_time":0,"source_url":"https://finance.yahoo.com/news/exclusive-vivani-medical-advances-obesity-120037399.html","article_id":"2470807757","we_media_id":null,"thumbnails":["https://s.yimg.com/uu/api/res/1.2/kWDm.hLcGXqQLLuMG8mTIQ--~B/aD01NTM7dz05ODM7YXBwaWQ9eXRhY2h5b24-/https://media.zenfs.com/en/Benzinga/cbb8a9acd219292bc8193581b5cd0671"],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2470807757","pubTimestamp":1727352037,"sourceInfo":{"source_id":"yahoofinance","name":"雅虎金融"},"weMediaInfo":null,"summary":"On Thursday, Vivani Medical, Inc.  announced that the Bellberry Human Research Ethics Committee has approved, and the Therapeutic Goods Administration in Australia has formally acknowledged a first-in-human clinical trial of the company's miniature, subdermal GLP-1  implant in obese and overweight subjects.What Happened: \"Securing regulatory approval keeps us on schedule to initiate this trial in Australia in the fourth quarter of 2024,\" said Vivani President and CEO Adam Mendelsohn.Also Read: EXCLUSIVE: Vivani Medical Outlines Plans To Kickstart First Clinical Study For Miniature GLP-1 Obesity Implant Program This Year.LIBERATE-1 will be a randomized investigation of the safety, tolerability, and pharmacokinetic profile of the exenatide NanoPortal implant in obese or overweight subjects.Weight changes will be measured. The trial is expected to be initiated later this year, and data is projected to be available in 2025.Why It Matters: \"Preclinical weight loss and liver fat data announc","collect":0,"end_time":0,"defaultTopTitle":"yahoo.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"BK4082":"医疗保健设备","VANI":"Vivani Medical, Inc.","BK4585":"ETF&股票定投概念","LU1093756168.USD":"FRANKLIN K2 ALTERNATIVE STRATEGIES \"A\" (USD) ACC","IE00BKVL7J92.USD":"Legg Mason ClearBridge - US Equity Sustainability Leaders A Acc USD","BK4588":"碎股","LU0154236417.USD":"BGF US FLEXIBLE EQUITY \"A2\" ACC","LU1093756325.SGD":"FTIF - Franklin K2 Alt Strat Fd A (acc) SGD-H1","BK4007":"制药","NVO":"诺和诺德","BK4532":"文艺复兴科技持仓","IE00BZ1G4Q59.USD":"LEGG MASON CLEARBRIDGE US EQUITY SUSTAINABILITY LEADER \"A\"(USD) INC (A)"},"translate_title":"独家：Vivani Medical在澳大利亚进行新的临床试验，推进其肥胖治疗植入物","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"VANI":0.9,"NVO":0.7},"content_text":"On Thursday, Vivani Medical, Inc. (NASDAQ:VANI) announced that the Bellberry Human Research Ethics Committee has approved, and the Therapeutic Goods Administration in Australia has formally acknowledged a first-in-human clinical trial of the company's miniature, subdermal GLP-1 (exenatide) implant in obese and overweight subjects.\nWhat Happened: \"Securing regulatory approval keeps us on schedule to initiate this trial in Australia in the fourth quarter of 2024,\" said Vivani President and CEO Adam Mendelsohn.\nAlso Read: EXCLUSIVE: Vivani Medical Outlines Plans To Kickstart First Clinical Study For Miniature GLP-1 Obesity Implant Program This Year.\nLIBERATE-1 will be a randomized investigation of the safety, tolerability, and pharmacokinetic profile of the exenatide NanoPortal implant in obese or overweight subjects.\nThe trial will enroll participants who will be titrated on weekly semaglutide injections for 8 weeks (0.25 mg/week for 4 weeks followed by 0.5 mg/week for 4 weeks) before being randomized to receive a single administration of Vivani's exenatide implant (n=8), weekly exenatide injections (n=8), or weekly 1 mg semaglutide injections (n=8) for 9-week treatment duration.\nWeight changes will be measured. The trial is expected to be initiated later this year, and data is projected to be available in 2025.\nWhy It Matters: \"Preclinical weight loss and liver fat data announced earlier this year supports the potential for our GLP-1 implant to provide comparable efficacy to semaglutide, the active ingredient in blockbuster products Ozempic and Wegovy, but with the significant benefit of twice-yearly administration,\" Mendelsohn added.\nOzempic and Wegovy are registered trademarks of Novo Nordisk A/S (NYSE:NVO).\nIf available, Vivani intends to utilize research and development incentives and rebates from the Australian government to defray a portion of the costs from the trial.\nSince clinical studies conducted in Australia comply with the International Conference on Harmonization guidelines and data generated in Australia are generally acceptable to the FDA and other regulatory authorities, Vivani anticipates using relevant clinical data generated in Australia to support regulatory submissions in other geographies, including the U.S.\nPrice Action: VANI stock closed at $1.18 on Wednesday.\nRead Next:\n\nFDA Casts Doubt On Use Of Merck, Bristol Myers' PD-1 Cancer Drugs For Certain Type Of Gastric Cancer Patients.\n\nUp Next: Transform your trading with Benzinga Edge's one-of-a-kind market trade ideas and tools. Click now to access unique insights that can set you ahead in today's competitive market.\nGet the latest stock analysis from Benzinga?\n\nThis article EXCLUSIVE: Vivani Medical Advances Its Obesity Treatment Implant With New Clinical Trial in Australia originally appeared on Benzinga.com\n© 2024 Benzinga.com. Benzinga does not provide investment advice. 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