{"id":55944,"date":"2023-04-18T14:06:22","date_gmt":"2023-04-18T12:06:22","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/lumicell-direct-visualization-system-premarket-approval-application-submitted-to-u-s-fda-for-intraoperative-breast-cancer-detection-and-removal\/"},"modified":"2023-04-18T14:06:22","modified_gmt":"2023-04-18T12:06:22","slug":"lumicell-direct-visualization-system-premarket-approval-application-submitted-to-u-s-fda-for-intraoperative-breast-cancer-detection-and-removal","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/lumicell-direct-visualization-system-premarket-approval-application-submitted-to-u-s-fda-for-intraoperative-breast-cancer-detection-and-removal\/","title":{"rendered":"Lumicell\u2122 Direct Visualization System Premarket Approval Application Submitted to U.S. FDA for Intraoperative Breast Cancer Detection and Removal"},"content":{"rendered":"<div>\n<ul class=\"bwlistdisc\">\n<li>\n<i>Visualization system designed for use with novel LUMISIGHT\u2122 Optical Imaging Agent to enable a more complete resection during initial lumpectomy<\/i><\/li>\n<li>\n<i>LUMISIGHT New Drug Application was submitted to the FDA in March<\/i><\/li>\n<li>\n<i>Lumicell DVS was previously granted Breakthrough Device designation by the FDA<\/i><\/li>\n<\/ul>\n<p>NEWTON, Mass.&#8211;(BUSINESS WIRE)&#8211;<a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Flumicell.com%2Findex.html&amp;esheet=53382683&amp;newsitemid=20230418005338&amp;lan=en-US&amp;anchor=Lumicell%2C+Inc&amp;index=1&amp;md5=639cfb7436faa8c77df50feded00200b\" rel=\"nofollow noopener\" shape=\"rect\">Lumicell, Inc<\/a>., a privately held company focused on innovative fluorescence-guided imaging technologies for cancer surgery, today announced a Premarket Approval (PMA) application for its Lumicell\u2122 Direct Visualization System (DVS) has been submitted to the U.S. Food and Drug Administration (FDA).<\/p>\n<p><a href=\"https:\/\/mms.businesswire.com\/media\/20230418005338\/en\/1765971\/5\/probe_lay_down_family_vial_w_syringe_no_needle.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20230418005338\/en\/1765971\/21\/probe_lay_down_family_vial_w_syringe_no_needle.jpg\"><\/a><br \/><a href=\"https:\/\/mms.businesswire.com\/media\/20230418005338\/en\/1765967\/5\/Lumicell_Logo-%28SSO%29.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20230418005338\/en\/1765967\/21\/Lumicell_Logo-%28SSO%29.jpg\"><\/a><\/p>\n<p>\nThe Lumicell\u2122 DVS is an investigational system designed for use in patients with breast cancer to assist in the detection of residual cancerous tissue within the lumpectomy cavity following removal of the primary specimen during breast conserving surgery. The Lumicell DVS is intended for use with LUMISIGHT\u2122 (pegulicianine) for fluorescence imaging of the lumpectomy cavity. The New Drug Application (NDA) for LUMISIGHT was <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Flumicell.com%2Fnews%2Fnews-press-releases-2023-03-21.php&amp;esheet=53382683&amp;newsitemid=20230418005338&amp;lan=en-US&amp;anchor=submitted+to+the+FDA&amp;index=2&amp;md5=05fbf0f496c4009505bb1a02d2240a26\" rel=\"nofollow noopener\" shape=\"rect\">submitted to the FDA<\/a> in March 2023.<\/p>\n<p>\n&#8220;The PMA submission for our Lumicell Direct Visualization System is the culmination of years of hard work from all of our clinical trial investigators and the Lumicell team,\u201d said Kevin Hershberger, president and chief executive officer of Lumicell. \u201cThis major milestone brings us one step closer to revolutionizing the way breast cancer surgery is performed and delivering meaningful clinical benefits to surgeons and patients.\u201d<\/p>\n<p>\nThe Lumicell DVS submission is supported by data from more than 700 breast cancer patients across five clinical studies at top academic and regional community cancer centers. Results from the Investigation of Novel Surgical Imaging for Tumor Excision (INSITE) pivotal trial (<a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fclinicaltrials.gov%2Fct2%2Fshow%2FNCT03686215&amp;esheet=53382683&amp;newsitemid=20230418005338&amp;lan=en-US&amp;anchor=NCT03686215&amp;index=3&amp;md5=c138992efc70c065f34435efbca89f20\" rel=\"nofollow noopener\" shape=\"rect\">NCT03686215<\/a>) of 406 patients at 14 sites will be presented at the upcoming American Society of Breast Surgeons (ASBrS) annual meeting. The FDA granted LUMISIGHT Fast Track designation and the Lumicell DVS Breakthrough Device designation in recognition of the potential important benefit of identifying residual cancer during the initial lumpectomy.<\/p>\n<p>\n\u201cThe current standard of care focuses on tissue that has already been removed instead of inside the patient where it matters,\u201d said Irene Wapnir, MD, professor of surgery at Stanford University School of Medicine and investigator of the INSITE clinical trial. \u201cA device like the Lumicell DVS which can look inside the breast cavity for residual cancer could be a crucial tool to help improve patient outcomes.\u201d<\/p>\n<p>\n<b>About the Lumicell Direct Visualization System<\/b><\/p>\n<p>\nThe investigational Lumicell Direct Visualization System (DVS) is intended for use with the investigational LUMISIGHT Optical Imaging Agent and features a hand-held imaging probe that is designed to go inside the breast cavity and a patient-calibrated cancer detection software to assist in the detection of residual cancer, thereby enabling a more complete resection. The safety and efficacy of the Lumicell DVS in detecting residual cancer left behind by standard of care surgical procedures has been evaluated in two studies: INSITE and a feasibility study of 234 patients at 16 sites, results of which were published in <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fjamanetwork.com%2Fjournals%2Fjamasurgery%2Ffullarticle%2F2792167&amp;esheet=53382683&amp;newsitemid=20230418005338&amp;lan=en-US&amp;anchor=JAMA+Surgery&amp;index=4&amp;md5=c796c732c8728b832b0be4dc573a2369\" rel=\"nofollow noopener\" shape=\"rect\">JAMA Surgery<\/a>.<\/p>\n<p>\nThe Lumicell DVS and LUMISIGHT are limited by Federal (or United States) law to investigational use only. The Lumicell DVS and LUMISIGHT are not commercially available.<\/p>\n<p>\n<b>About Lumicell, Inc.<\/b><\/p>\n<p>\nLumicell is a privately held company focused on improving surgical outcomes and reducing healthcare costs by utilizing its innovative fluorescence-guided surgical technologies to enable a more complete resection of cancer that may have otherwise been left behind. The company\u2019s first product in development is the Lumicell Direct Visualization System, designed to illuminate cancerous tissue within the breast cavity during the initial lumpectomy procedure. Lumicell\u2019s proprietary, pan-oncologic optical imaging agent LUMISIGHT is also being explored across a wide variety of solid tumor indications. For more information, please visit <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.lumicell.com%2F&amp;esheet=53382683&amp;newsitemid=20230418005338&amp;lan=en-US&amp;anchor=www.lumicell.com&amp;index=5&amp;md5=8a024a9c78f8d6d2ffc1ccba277dc440\" rel=\"nofollow noopener\" shape=\"rect\">www.lumicell.com<\/a> and follow the company on <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.facebook.com%2FLumicellSurg&amp;esheet=53382683&amp;newsitemid=20230418005338&amp;lan=en-US&amp;anchor=Facebook&amp;index=6&amp;md5=9647694a8cb0f897ec7ae9c0c464edde\" rel=\"nofollow noopener\" shape=\"rect\">Facebook<\/a>, <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Ftwitter.com%2FLumicellSurg&amp;esheet=53382683&amp;newsitemid=20230418005338&amp;lan=en-US&amp;anchor=Twitter&amp;index=7&amp;md5=083c3af7e8795b2ddc2e8a57fdff3181\" rel=\"nofollow noopener\" shape=\"rect\">Twitter<\/a> and <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2F1941596&amp;esheet=53382683&amp;newsitemid=20230418005338&amp;lan=en-US&amp;anchor=LinkedIn&amp;index=8&amp;md5=f144c25f57755b80e5dfd38f2d2a636e\" rel=\"nofollow noopener\" shape=\"rect\">LinkedIn<\/a>.<\/p>\n<p> <b>Contacts<\/b> <\/p>\n<p>\nJoni Ramirez<br \/>\n<br \/>Merryman Communications<br \/>\n<br \/><a target=\"_blank\" href=\"&#x6d;&#97;i&#x6c;&#x74;&#111;:&#x6a;&#x6f;&#110;i&#x40;&#x6d;&#101;r&#x72;&#x79;&#109;a&#x6e;&#99;&#111;m&#x6d;&#117;n&#x69;&#x63;&#97;t&#x69;&#x6f;&#110;s&#x2e;&#x63;&#111;m\" rel=\"nofollow noopener\" shape=\"rect\">j&#111;&#x6e;&#x69;&#x40;m&#101;&#x72;&#x72;&#x79;m&#97;&#x6e;&#x63;&#x6f;m&#109;&#x75;&#x6e;&#x69;c&#97;&#x74;&#x69;&#x6f;n&#115;&#x2e;&#x63;&#x6f;m<\/a><br \/>323-532-0746<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Visualization system designed for use with novel LUMISIGHT\u2122 Optical Imaging Agent to enable a more complete resection during initial lumpectomy LUMISIGHT New Drug Application was submitted to the FDA in March Lumicell DVS was previously granted Breakthrough Device designation by the FDA NEWTON, Mass.&#8211;(BUSINESS WIRE)&#8211;Lumicell, Inc., a privately held company focused on innovative fluorescence-guided imaging &#8230; <span class=\"more\"><a class=\"more-link\" href=\"https:\/\/pharma-trend.com\/en\/lumicell-direct-visualization-system-premarket-approval-application-submitted-to-u-s-fda-for-intraoperative-breast-cancer-detection-and-removal\/\">[Read more&#8230;]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-55944","6":"format-standard","7":"category-industry"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Lumicell\u2122 Direct Visualization System Premarket Approval Application Submitted to U.S. FDA for Intraoperative Breast Cancer Detection and Removal - Pharma Trend<\/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:\/\/pharma-trend.com\/en\/lumicell-direct-visualization-system-premarket-approval-application-submitted-to-u-s-fda-for-intraoperative-breast-cancer-detection-and-removal\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Lumicell\u2122 Direct Visualization System Premarket Approval Application Submitted to U.S. FDA for Intraoperative Breast Cancer Detection and Removal - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"Visualization system designed for use with novel LUMISIGHT\u2122 Optical Imaging Agent to enable a more complete resection during initial lumpectomy LUMISIGHT New Drug Application was submitted to the FDA in March Lumicell DVS was previously granted Breakthrough Device designation by the FDA NEWTON, Mass.&#8211;(BUSINESS WIRE)&#8211;Lumicell, Inc., a privately held company focused on innovative fluorescence-guided imaging ... 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