NeuroPace Submits FDA Application to Expand RNS System Indication for Drug-Resistant Epilepsy

Reuters2025-12-17

NeuroPace Submits FDA Application to Expand RNS System Indication for Drug-Resistant Epilepsy

NeuroPace, Inc. has filed a Premarket Approval Supplement (PMA-S) application with the U.S. Food and Drug Administration (FDA) seeking to expand the labeled indication for its RNS System to include patients with antiseizure-medication resistant idiopathic generalized epilepsy $(IGE)$ with generalized tonic-clonic seizures. The submission is supported by positive preliminary 18-month data from the NAUTILUS clinical trial. The company aims to provide new treatment options for patients with drug-resistant IGE, who currently lack approved neuromodulation therapies.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Neuropace Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 20251217370604) on December 17, 2025, and is solely responsible for the information contained therein.

Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.

Comments

We need your insight to fill this gap

Leave a comment

{"i18n":{"language":"en_US"},"isChannel":false,"data":{"share":"https://ttm.financial/m/news/2592899091?lang=en_US&edition=fundamental","thumbnail":"","is_english":true,"pubTime":"2025-12-17 21:00","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"2592899091","market":"us","top_or_hot":-1,"title":"NeuroPace Submits FDA Application to Expand RNS System Indication for Drug-Resistant Epilepsy","media":"Reuters","content":"<html xmlns=\"http://www.w3.org/1999/xhtml\" xmlns:newsg2=\"http://iptc.org/std/nar/2006-10-01/\" xmlns:xhtml=\"http://www.w3.org/1999/xhtml\"><head><title>\n      NeuroPace Submits FDA Application to Expand RNS System Indication for Drug-Resistant Epilepsy\n    </title></head><body><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<p>\n        NeuroPace, Inc. has filed a Premarket Approval Supplement (PMA-S) application with the U.S. Food and Drug Administration (FDA) seeking to expand the labeled indication for its RNS System to include patients with antiseizure-medication resistant idiopathic generalized epilepsy <a href=\"https://laohu8.com/S/IGE\">$(IGE)$</a> with generalized tonic-clonic seizures. The submission is supported by positive preliminary 18-month data from the NAUTILUS clinical trial. The company aims to provide new treatment options for patients with drug-resistant IGE, who currently lack approved neuromodulation therapies.\n      </p>\n</div><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<em>Disclaimer: <span>This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Neuropace Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 20251217370604) on December 17, 2025, and is solely responsible for the information contained therein.</span></em>\n</div></body></html>","source":null,"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>NeuroPace Submits FDA Application to Expand RNS System Indication for Drug-Resistant Epilepsy</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\">\nNeuroPace Submits FDA Application to Expand RNS System Indication for Drug-Resistant Epilepsy\n</h2>\n\n<h4 class=\"meta\">\n\n\n<a class=\"head\" href=\"https://laohu8.com/wemedia/1032215980\">\n\n\n<div class=\"h-thumb\" style=\"background-image:url(https://community-static.tradeup.com/news/4567337cbdf294b657b1fa87c5488b48);background-size:cover;\"></div>\n\n<div class=\"h-content\">\n<p class=\"h-name\">Reuters </p>\n<p class=\"h-time\">2025-12-17 21:00</p>\n</div>\n\n</a>\n\n\n</h4>\n\n</header>\n<article>\n<html xmlns=\"http://www.w3.org/1999/xhtml\" xmlns:newsg2=\"http://iptc.org/std/nar/2006-10-01/\" xmlns:xhtml=\"http://www.w3.org/1999/xhtml\"><head><title>\n      NeuroPace Submits FDA Application to Expand RNS System Indication for Drug-Resistant Epilepsy\n    </title></head><body><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<p>\n        NeuroPace, Inc. has filed a Premarket Approval Supplement (PMA-S) application with the U.S. Food and Drug Administration (FDA) seeking to expand the labeled indication for its RNS System to include patients with antiseizure-medication resistant idiopathic generalized epilepsy <a href=\"https://laohu8.com/S/IGE\">$(IGE)$</a> with generalized tonic-clonic seizures. The submission is supported by positive preliminary 18-month data from the NAUTILUS clinical trial. The company aims to provide new treatment options for patients with drug-resistant IGE, who currently lack approved neuromodulation therapies.\n      </p>\n</div><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<em>Disclaimer: <span>This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Neuropace Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 20251217370604) on December 17, 2025, and is solely responsible for the information contained therein.</span></em>\n</div></body></html>\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://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20251217:nNDL5xykKK:1","article_id":"2592899091","we_media_id":"1032215980","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2592899091","pubTimestamp":1765976453,"columns":[],"sourceInfo":null,"weMediaInfo":{"media_name":"Reuters","introduction":"Reuters.com brings you the latest news from around the world, covering breaking news in markets, business, politics, entertainment and technology","home_visible":1,"id":"1032215980","head_image":"https://community-static.tradeup.com/news/4567337cbdf294b657b1fa87c5488b48"},"summary":"NeuroPace, Inc. has filed a Premarket Approval Supplement  application with the U.S. Food and Drug Administration  seeking to expand the labeled indication for its RNS System to include patients with antiseizure-medication resistant idiopathic generalized epilepsy  with generalized tonic-clonic seizures. The submission is supported by positive preliminary 18-month data from the NAUTILUS clinical trial. The company aims to provide new treatment options for patients with drug-resistant IGE, who currently lack approved neuromodulation therapies.Disclaimer: This news brief was created by Public Technologies  using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Neuropace Inc. published the original content used to generate this news brief via Business Wire  on December 17, 2025, and is solely responsible for","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"BK4082":"医疗保健设备","NPCE":"NeuroPace Inc.","BK4539":"次新股"},"translate_title":"NeuroPace向FDA提交扩大RNS系统适应症用于耐药性癫痫的申请","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"NPCE":0.9},"content_text":"NeuroPace Submits FDA Application to Expand RNS System Indication for Drug-Resistant Epilepsy\n    \n\n        NeuroPace, Inc. has filed a Premarket Approval Supplement (PMA-S) application with the U.S. Food and Drug Administration (FDA) seeking to expand the labeled indication for its RNS System to include patients with antiseizure-medication resistant idiopathic generalized epilepsy $(IGE)$ with generalized tonic-clonic seizures. The submission is supported by positive preliminary 18-month data from the NAUTILUS clinical trial. The company aims to provide new treatment options for patients with drug-resistant IGE, who currently lack approved neuromodulation therapies.\n      \n\nDisclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Neuropace Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 20251217370604) on December 17, 2025, and is solely responsible for the information contained therein.","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"","news_rank":0,"symbols":[],"gpt_button":0,"need_auth":false,"code":"91000000","status":"200"},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)","isDev":false,"isTTM":true,"tenantId":"TBGLOBAL","deviceId":"web-server-community-laohu8-v3","version":"4.36.0","shortVersion":"4.36.0","platform":"web","vendor":"web","appName":"ttm","isIOS":false,"isAndroid":false,"isTiger":false,"isTHS":false,"isWeiXin":false,"isWeiXinMini":false,"isWeiBo":false,"isQQ":false,"isBaiduSwan":false,"isBaiduBox":false,"isDingTalk":false,"isToutiao":false,"isOnePlus":false,"isHuaWei":false,"isXiaomi":false,"isXiaomiWebView":false,"isOppo":false,"isVivo":false,"isSamsung":false,"isMobile":false},"href":"/m/news/2592899091","isCrawlerRequest":true}