{"id":780930,"date":"2023-08-30T09:05:58","date_gmt":"2023-08-30T13:05:58","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/endra-life-sciences-taeus-de-novo-submission-advances-to-next-stage-of-review-with-fda\/"},"modified":"2023-08-30T09:05:58","modified_gmt":"2023-08-30T13:05:58","slug":"endra-life-sciences-taeus-de-novo-submission-advances-to-next-stage-of-review-with-fda","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/endra-life-sciences-taeus-de-novo-submission-advances-to-next-stage-of-review-with-fda\/","title":{"rendered":"ENDRA Life Sciences’ TAEUS De Novo Submission Advances to Next Stage of Review with FDA"},"content":{"rendered":"

<\/p>\n

ENDRA Life Sciences’ TAEUS De Novo Submission <\/b>Advances to Next Stage of Review with FDA<\/b><\/p>\n

ANN ARBOR, Mich.–(BUSINESS WIRE<\/a>)–ENDRA Life Sciences Inc.<\/b><\/a>(NASDAQ: NDRA), a pioneer of imaging technologies and Thermo Acoustic Enhanced UltraSound (TAEUS\u00ae<\/sup>), announces that the Company’s De Novo request for the TAEUS liver system has advanced to substantive review with the U.S. Food and Drug Administration (FDA). The TAEUS system is ENDRA\u2019s proprietary device that is intended to offer clinicians a tool for the non-invasive assessment of fatty liver tissue, as an aid in the management of patients with Non-Alcoholic Fatty Liver Disease (NAFLD).<\/p>\n

\n\u201cWe are very pleased that our FDA De Novo submission has advanced to the substantive review stage,” stated ENDRA’s Chairman and Chief Executive Officer Francois Michelon. “ENDRA is committed to bringing the TAEUS technology to the U.S market to help clinicians combat the global epidemic of fatty liver disease, which affects over one billion people globally. We look forward to supporting the FDA as they continue their review.”<\/p>\n

\nOn August 14, 2023, ENDRA submitted a De Novo request to the FDA using the electronic Submission Template And Resource (eSTAR) system. On August 29, 2023, FDA informed ENDRA that the Company’s submission was entering the substantive review period. The FDA’s goal is to make a decision about a De Novo request in 150 review days.<\/p>\n

\nThe De Novo pathway provides a way to classify novel medical devices for which there is no legally marketed predicate device and if granted, will strengthen TAEUS\u2019 competitive position with its distinctive, patent-protected capabilities as a non-invasive point-of-care tool to aid in the characterization of NAFLD.<\/p>\n

About ENDRA Life Sciences Inc.<\/b><\/p>\n

\nENDRA Life Sciences is the pioneer of Thermo Acoustic Enhanced UltraSound (TAEUS\u00ae<\/sup>), a ground-breaking technology being developed to visualize tissue like MRI, but at 1\/50th<\/sup> the cost and at the point of patient care. TAEUS\u00ae<\/sup> is designed to work in concert with over 500,000 ultrasound systems in use globally today. TAEUS\u00ae<\/sup> is initially focused on the measurement of fat in the liver as a means to assess and monitor Steatotic Liver Disease (SLD) (formerly known as NAFLD-NASH), a chronic liver spectrum that affects over one billion people globally, and for which there are no practical diagnostic tools. Beyond the liver, ENDRA is exploring several other clinical applications of TAEUS\u00ae<\/sup>, including visualization of tissue temperature during energy-based surgical procedures. For more information, please visit www.endrainc.com<\/a>.<\/p>\n

Forward-Looking Statements<\/b><\/p>\n

\nAll statements in this press release that are not based on historical fact are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements, which are based on certain assumptions and describe our future plans, strategies and expectations, can generally be identified by the use of terms such as \u201capproximate,\u201d “anticipate,” \u201cattempt,\u201d “believe,” “could,” “estimate,” “expect,” \u201cforecast,\u201d \u201cfuture,\u201d “goal,” \u201chope,\u201d “intend,” “may,” “plan,” \u201cpossible,\u201d \u201cpotential,\u201d \u201cproject,\u201d “seek,” “should,” “will,” \u201cwould,\u201d or other comparable terms (including the negative of any of the foregoing), although some forward-looking statements are expressed differently. Examples of forward-looking statements for ENDRA include, among others: estimates of the timing of future events and anticipated results of our development efforts, including the timing for receipt of required regulatory approvals and product launches; future financial position and projected costs and revenue; expectations concerning ENDRA’s business strategy; ENDRA\u2019s ability to find and maintain development partners; market acceptance of ENDRA\u2019s technology and the amount and nature of competition in its industry; and ENDRA\u2019s ability to protect its intellectual property. Forward-looking statements involve inherent risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements as a result of various factors including, among others: the ability to raise additional capital in order to continue as a going concern; the ability to obtain regulatory approvals necessary to sell ENDRA medical devices in certain markets in a timely manner, or at all; the ability to develop a commercially feasible technology and its dependence on third parties to design and manufacture its products; the impact of COVID-19 on ENDRA\u2019s business plans; the ability to find and maintain development partners; market acceptance of ENDRA\u2019s technology and the amount and nature of competition in its industry; ENDRA\u2019s ability to protect its intellectual property; and the other risks and uncertainties described in the Risk Factors and Management\u2019s Discussion and Analysis of Financial Condition and Results of Operations sections of the Company\u2019s most recent Annual Report on Form 10-K and in subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission. You should not rely upon forward-looking statements as predictions of future events. The forward-looking statements made in this press release speak only as of the date of issuance, and ENDRA assumes no obligation to update any such forward-looking statements to reflect actual results or changes in expectations, except as otherwise required by law.<\/p>\n

\"\"<\/p>\n

View source version on businesswire.com: <\/span>https:\/\/www.businesswire.com\/news\/home\/20230830381163\/en\/<\/a><\/span><\/p>\n

\nIrina Pestrikova
\n
Senior Director, Finance
\n
investors@endrainc.com
\n<\/a>
www.endrainc.com
\n<\/a><\/p>\n

Investor Relations:
\n<\/b>
Yvonne Briggs
\n
LHA Investor Relations
\n
(310) 691-7100
\n
YBriggs@lhai.com<\/a><\/p>\n

KEYWORDS:<\/b> United States North America Michigan<\/p>\n

INDUSTRY KEYWORDS:<\/b> Health Technology Health Other Health Medical Devices<\/p>\n

MEDIA:<\/b><\/p>\n\n","protected":false},"excerpt":{"rendered":"

ENDRA Life Sciences’ TAEUS De Novo Submission Advances to Next Stage of Review with FDA ANN ARBOR, Mich.–(BUSINESS WIRE)–ENDRA Life Sciences Inc.(NASDAQ: NDRA), a pioneer of imaging technologies and Thermo Acoustic Enhanced UltraSound (TAEUS\u00ae), announces that the Company’s De Novo request for the TAEUS liver system has advanced to substantive review with the U.S. Food and Drug Administration (FDA). The TAEUS system is ENDRA\u2019s proprietary device that is intended to offer clinicians a tool for the non-invasive assessment of fatty liver tissue, as an aid in the management of patients with Non-Alcoholic Fatty Liver Disease (NAFLD). \u201cWe are very pleased that our FDA De Novo submission has advanced to the substantive review stage,” stated ENDRA’s Chairman and Chief Executive Officer … <\/p>\n

Continue reading “ENDRA Life Sciences’ TAEUS De Novo Submission Advances to Next Stage of Review with FDA”<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-780930","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nENDRA Life Sciences' TAEUS De Novo Submission Advances to Next Stage of Review with FDA - Market Newsdesk<\/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.marketnewsdesk.com\/index.php\/endra-life-sciences-taeus-de-novo-submission-advances-to-next-stage-of-review-with-fda\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"ENDRA Life Sciences' TAEUS De Novo Submission Advances to Next Stage of Review with FDA - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"ENDRA Life Sciences’ TAEUS De Novo Submission Advances to Next Stage of Review with FDA ANN ARBOR, Mich.–(BUSINESS WIRE)–ENDRA Life Sciences Inc.(NASDAQ: NDRA), a pioneer of imaging technologies and Thermo Acoustic Enhanced UltraSound (TAEUS\u00ae), announces that the Company’s De Novo request for the TAEUS liver system has advanced to substantive review with the U.S. Food and Drug Administration (FDA). The TAEUS system is ENDRA\u2019s proprietary device that is intended to offer clinicians a tool for the non-invasive assessment of fatty liver tissue, as an aid in the management of patients with Non-Alcoholic Fatty Liver Disease (NAFLD). \u201cWe are very pleased that our FDA De Novo submission has advanced to the substantive review stage,” stated ENDRA’s Chairman and Chief Executive Officer … Continue reading "ENDRA Life Sciences’ TAEUS De Novo Submission Advances to Next Stage of Review with FDA"\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/endra-life-sciences-taeus-de-novo-submission-advances-to-next-stage-of-review-with-fda\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2023-08-30T13:05:58+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&sty=20230830381163r1&sid=flmnd&distro=nx&lang=en\" \/>\n<meta name=\"author\" content=\"Newsdesk\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Newsdesk\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"4 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/endra-life-sciences-taeus-de-novo-submission-advances-to-next-stage-of-review-with-fda\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/endra-life-sciences-taeus-de-novo-submission-advances-to-next-stage-of-review-with-fda\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"ENDRA Life Sciences’ TAEUS De Novo Submission Advances to Next Stage of Review with FDA\",\"datePublished\":\"2023-08-30T13:05:58+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/endra-life-sciences-taeus-de-novo-submission-advances-to-next-stage-of-review-with-fda\\\/\"},\"wordCount\":883,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/endra-life-sciences-taeus-de-novo-submission-advances-to-next-stage-of-review-with-fda\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/cts.businesswire.com\\\/ct\\\/CT?id=bwnews&sty=20230830381163r1&sid=flmnd&distro=nx&lang=en\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/endra-life-sciences-taeus-de-novo-submission-advances-to-next-stage-of-review-with-fda\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/endra-life-sciences-taeus-de-novo-submission-advances-to-next-stage-of-review-with-fda\\\/\",\"name\":\"ENDRA Life Sciences' TAEUS De Novo Submission Advances to Next Stage of Review with FDA - 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