{"id":416033,"date":"2021-01-15T17:02:01","date_gmt":"2021-01-15T22:02:01","guid":{"rendered":"http:\/\/www.marketnewsdesk.com\/?p=416033"},"modified":"2021-01-15T17:02:01","modified_gmt":"2021-01-15T22:02:01","slug":"neovasc-responds-to-fda-not-approvable-letter-regarding-neovasc-reducer","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/neovasc-responds-to-fda-not-approvable-letter-regarding-neovasc-reducer\/","title":{"rendered":"Neovasc Responds to FDA Not-Approvable Letter Regarding Neovasc Reducer\u2122"},"content":{"rendered":"<div class=\"mw_release\">\n<p>VANCOUVER and MINNEAPOLIS, Jan.  15, 2021  (GLOBE NEWSWIRE) &#8212; via <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=54_OppnJjnIMCx8adTnJ2nURnTotixX_BBOj8giVRHtCwk8O9KHno2xBMwdAWSMBVgbOwZ3pDNl337-8Qwu5WQ==\" rel=\"nofollow noopener noreferrer\" target=\"_blank\">NewMediaWire<\/a> &#8212; <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=KHM4XIt6l2lyEwNyd4YDVS-j5fQALLb35bUHurSmcRcn-pUQMvlx3LiFDfKI8T9-JRzyhTkQHc1EQT06ubY3I5_D8pA4RB0LIvZlg7ETIigOA0-bqwWHZJaSjcXEGdna\" rel=\"nofollow noopener noreferrer\" target=\"_blank\">Neovasc Inc<\/a>. (\u201cNeovasc\u201d or the \u201cCompany\u201d) (<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=8JMscczxBQk3zV0Ub-tkBOn5_Z21zn7VjjjKzhzD9A-cY7uv2bDqessgMq-nBUV34s5QFGsAXEkjcNnC1xSDVsFK8oJNZCpcKyU-SczQM_E=\" rel=\"nofollow noopener noreferrer\" target=\"_blank\">Nasdaq<\/a>, <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=WQflxqpBE48egkS7Oix2p0m1aPYx2OnRMue5boEGkFYVxyZhXR36eLH6IT470ped75pMN9XxJ7BRblahKQsRE3OpWbWIXDQ7a_MC6_vVtOY=\" rel=\"nofollow noopener noreferrer\" target=\"_blank\">TSX<\/a>: NVCN) announced today that it has received a \u201cnot-approvable\u201d letter from U.S. Food &amp; Drug Administration (FDA) regarding its PMA submission for the Neovasc Reducer\u2122 (Reducer).\u00a0\u00a0<\/p>\n<p>Fred Colen, Neovasc CEO, said, \u201cWhile we are disappointed in FDA\u2019s decision, the letter was not unexpected, given the outcome of the Panel meeting.\u201d He continued, \u201cMillions of patients suffer from refractory angina, and for many, the Reducer offers hope for symptom relief. We will continue to evaluate our strategic options for bringing the Reducer to patients around the world.\u201d<\/p>\n<p>The FDA reviewed Reducer for treatment of patients with refractory angina pectoris despite guideline directed medical therapy, who are unsuitable for revascularization by coronary artery bypass grafting or by percutaneous coronary intervention. The Reducer is CE-marked in the European Union for the treatment of refractory angina.<\/p>\n<p>\n        <b>About Neovasc Inc.\u00a0<\/b>\n      <\/p>\n<p>Neovasc is a specialty medical device company that develops, manufactures and markets products for the rapidly growing cardiovascular marketplace. Its products include Reducer, for the treatment of refractory angina, which is not currently commercially available in the United States and has been commercially available in Europe since 2015, and Tiara, for the transcatheter treatment of mitral valve disease, which is currently under clinical investigation in the United States, Canada, Israel and Europe. For more information, visit: <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=PMgwNqi2eCPD0vAe5ZCDLYYB9xG5LswqM_li8rP2NUDpXDQqoZ-i19jYLnEMqp_07l09icgtwcLccgSJBQmm6g==\" rel=\"nofollow noopener noreferrer\" target=\"_blank\">www.neovasc.com<\/a>.<\/p>\n<p>\n        <b>Forward-Looking Statement Disclaimer<\/b>\n      <\/p>\n<p>Certain statements in this news release contain forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and applicable Canadian securities laws that may not be based on historical fact.\u00a0When used herein, the words &#8220;expect&#8221;, &#8220;anticipate&#8221;, &#8220;estimate&#8221;, &#8220;may&#8221;, &#8220;will&#8221;, &#8220;should&#8221;, &#8220;intend,&#8221; &#8220;believe&#8221;, and similar expressions, are intended to identify forward-looking statements. Forward-looking statements may involve, but are not limited to, the safety and effectiveness of the Reducer and the growing cardiovascular marketplace. Forward-looking statements are based on estimates and assumptions made by the Company in light of its experience and its perception of historical trends, current conditions and expected future developments, market and other conditions as well as other factors that the Company believes are appropriate in the circumstances. Many factors could cause the Company&#8217;s actual results, performance or achievements to differ materially from those expressed or implied by the forward-looking statements, including those described in the &#8220;Risk Factors&#8221; section of the Company&#8217;s Annual Report on Form 20-F and in the Management&#8217;s Discussion and Analysis for the three and nine months ended September 30, 2020 (copies of which may be obtained at\u00a0www.sedar.com\u00a0or\u00a0www.sec.gov). These factors should be considered carefully, and readers should not place undue reliance on the Company&#8217;s forward-looking statements. The Company has no intention and undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.<\/p>\n<p>\n        <b>Investors<\/b>\n      <\/p>\n<p>Mike Cavanaugh<br \/>Westwicke\/ICR<br \/>Phone: +1.646.877.9641<br \/><a href=\"https:\/\/www.globenewswire.com\/Tracker?data=zgjQotYxBfBASFch-GU7WXKv47iaCvFRqxF77LzI39T54V3sZl-T8ETOg0Ty0woPTiWLeRmSx8pWlhaxGgxYVeFaBll9QvI-aOewaer0X3lNK2vMd1Ps7p2u1YVwkTQu\" rel=\"nofollow noopener noreferrer\" target=\"_blank\">Mike.Cavanaugh@westwicke.com<\/a><\/p>\n<p>\n        <b>Media<\/b><br \/>\n        <br \/>Sean Leous<br \/>Westwicke\/ICR<br \/>Phone: +1.646.866.4012<br \/><a href=\"https:\/\/www.globenewswire.com\/Tracker?data=QNyQTXp1ZOW1o2JFhtBrLsAa12k0HvVITmEXO0bsORA9zgdQOnwZ_XF237Ng7VFoLoykQSyyM6x7jv1uaJnq-_tuan4d1XBcbkNCRlGYVyU=\" rel=\"nofollow noopener noreferrer\" target=\"_blank\">Sean.Leous@westwicke.com<\/a><\/p>\n<p \/>\n      <img loading=\"lazy\" decoding=\"async\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODEyNjg3MSMzOTIxNzk1IzUwMDA2ODg0Mw==\" width=\"1\" height=\"1\" \/><br \/>\n      <br \/>\n      <img loading=\"lazy\" decoding=\"async\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/ml.globenewswire.com\/release\/track\/d34f715d-7826-4119-ac29-ed457ed7e96d\" width=\"1\" height=\"1\" \/>\n    <\/div>\n<div class=\"mw_contactinfo\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>VANCOUVER and MINNEAPOLIS, Jan. 15, 2021 (GLOBE NEWSWIRE) &#8212; via NewMediaWire &#8212; Neovasc Inc. (\u201cNeovasc\u201d or the \u201cCompany\u201d) (Nasdaq, TSX: NVCN) announced today that it has received a \u201cnot-approvable\u201d letter from U.S. Food &amp; Drug Administration (FDA) regarding its PMA submission for the Neovasc Reducer\u2122 (Reducer).\u00a0\u00a0 Fred Colen, Neovasc CEO, said, \u201cWhile we are disappointed in FDA\u2019s decision, the letter was not unexpected, given the outcome of the Panel meeting.\u201d He continued, \u201cMillions of patients suffer from refractory angina, and for many, the Reducer offers hope for symptom relief. We will continue to evaluate our strategic options for bringing the Reducer to patients around the world.\u201d The FDA reviewed Reducer for treatment of patients with refractory angina pectoris despite guideline &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/neovasc-responds-to-fda-not-approvable-letter-regarding-neovasc-reducer\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Neovasc Responds to FDA Not-Approvable Letter Regarding Neovasc Reducer\u2122&#8221;<\/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-416033","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Neovasc Responds to FDA Not-Approvable Letter Regarding Neovasc Reducer\u2122 - 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\/neovasc-responds-to-fda-not-approvable-letter-regarding-neovasc-reducer\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Neovasc Responds to FDA Not-Approvable Letter Regarding Neovasc Reducer\u2122 - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"VANCOUVER and MINNEAPOLIS, Jan. 15, 2021 (GLOBE NEWSWIRE) &#8212; via NewMediaWire &#8212; Neovasc Inc. (\u201cNeovasc\u201d or the \u201cCompany\u201d) (Nasdaq, TSX: NVCN) announced today that it has received a \u201cnot-approvable\u201d letter from U.S. Food &amp; Drug Administration (FDA) regarding its PMA submission for the Neovasc Reducer\u2122 (Reducer).\u00a0\u00a0 Fred Colen, Neovasc CEO, said, \u201cWhile we are disappointed in FDA\u2019s decision, the letter was not unexpected, given the outcome of the Panel meeting.\u201d He continued, \u201cMillions of patients suffer from refractory angina, and for many, the Reducer offers hope for symptom relief. We will continue to evaluate our strategic options for bringing the Reducer to patients around the world.\u201d The FDA reviewed Reducer for treatment of patients with refractory angina pectoris despite guideline &hellip; Continue reading &quot;Neovasc Responds to FDA Not-Approvable Letter Regarding Neovasc Reducer\u2122&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/neovasc-responds-to-fda-not-approvable-letter-regarding-neovasc-reducer\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2021-01-15T22:02:01+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODEyNjg3MSMzOTIxNzk1IzUwMDA2ODg0Mw==\" \/>\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=\"2 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\\\/neovasc-responds-to-fda-not-approvable-letter-regarding-neovasc-reducer\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/neovasc-responds-to-fda-not-approvable-letter-regarding-neovasc-reducer\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"Neovasc Responds to FDA Not-Approvable Letter Regarding Neovasc Reducer\u2122\",\"datePublished\":\"2021-01-15T22:02:01+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/neovasc-responds-to-fda-not-approvable-letter-regarding-neovasc-reducer\\\/\"},\"wordCount\":499,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/neovasc-responds-to-fda-not-approvable-letter-regarding-neovasc-reducer\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.globenewswire.com\\\/newsroom\\\/ti?nf=ODEyNjg3MSMzOTIxNzk1IzUwMDA2ODg0Mw==\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/neovasc-responds-to-fda-not-approvable-letter-regarding-neovasc-reducer\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/neovasc-responds-to-fda-not-approvable-letter-regarding-neovasc-reducer\\\/\",\"name\":\"Neovasc Responds to FDA Not-Approvable Letter Regarding Neovasc Reducer\u2122 - 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(\u201cNeovasc\u201d or the \u201cCompany\u201d) (Nasdaq, TSX: NVCN) announced today that it has received a \u201cnot-approvable\u201d letter from U.S. Food &amp; Drug Administration (FDA) regarding its PMA submission for the Neovasc Reducer\u2122 (Reducer).\u00a0\u00a0 Fred Colen, Neovasc CEO, said, \u201cWhile we are disappointed in FDA\u2019s decision, the letter was not unexpected, given the outcome of the Panel meeting.\u201d He continued, \u201cMillions of patients suffer from refractory angina, and for many, the Reducer offers hope for symptom relief. We will continue to evaluate our strategic options for bringing the Reducer to patients around the world.\u201d The FDA reviewed Reducer for treatment of patients with refractory angina pectoris despite guideline &hellip; Continue reading \"Neovasc Responds to FDA Not-Approvable Letter Regarding Neovasc Reducer\u2122\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/neovasc-responds-to-fda-not-approvable-letter-regarding-neovasc-reducer\/","og_site_name":"Market Newsdesk","article_published_time":"2021-01-15T22:02:01+00:00","og_image":[{"url":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODEyNjg3MSMzOTIxNzk1IzUwMDA2ODg0Mw==","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"2 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/neovasc-responds-to-fda-not-approvable-letter-regarding-neovasc-reducer\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/neovasc-responds-to-fda-not-approvable-letter-regarding-neovasc-reducer\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"Neovasc Responds to FDA Not-Approvable Letter Regarding Neovasc Reducer\u2122","datePublished":"2021-01-15T22:02:01+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/neovasc-responds-to-fda-not-approvable-letter-regarding-neovasc-reducer\/"},"wordCount":499,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/neovasc-responds-to-fda-not-approvable-letter-regarding-neovasc-reducer\/#primaryimage"},"thumbnailUrl":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODEyNjg3MSMzOTIxNzk1IzUwMDA2ODg0Mw==","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/neovasc-responds-to-fda-not-approvable-letter-regarding-neovasc-reducer\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/neovasc-responds-to-fda-not-approvable-letter-regarding-neovasc-reducer\/","name":"Neovasc Responds to FDA Not-Approvable Letter Regarding Neovasc Reducer\u2122 - 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