{"id":470731,"date":"2021-04-05T08:04:31","date_gmt":"2021-04-05T12:04:31","guid":{"rendered":"http:\/\/www.marketnewsdesk.com\/?p=470731"},"modified":"2021-04-05T08:04:31","modified_gmt":"2021-04-05T12:04:31","slug":"icecure-medical-granted-fda-breakthrough-device-designation-for-prosense-cryoablation-system","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/icecure-medical-granted-fda-breakthrough-device-designation-for-prosense-cryoablation-system\/","title":{"rendered":"IceCure Medical Granted FDA Breakthrough Device Designation for ProSense\u00ae Cryoablation System"},"content":{"rendered":"<div class=\"xn-newslines\">\n<h2 class=\"xn-hedline\">&#8211; Treatment for patients with T1 invasive breast cancer and\/or breast cancer for patients not suitable for surgical alternatives included in the indications being reviewed<\/h2>\n<p class=\"xn-distributor\">PR Newswire<\/p>\n<\/p><\/div>\n<div class=\"xn-content\">\n<p>\n        <span class=\"xn-location\">CAESAREA, Israel<\/span>, <span class=\"xn-chron\">April 5, 2021<\/span> \/PRNewswire\/ &#8212;\u00a0<a target=\"_blank\" href=\"https:\/\/icecure-medical.com\/\" rel=\"nofollow noopener noreferrer\">IceCure Medical Ltd.<\/a> (TASE: ICCM) (&#8220;IceCure&#8221; or the &#8220;Company&#8221;), developer of the next generation cryoablation technology that destroys tumors by freezing, announced today that it has been granted Designation as a Breakthrough Device from the U.S. Food and Drug Administration (FDA) for its lead asset, <a target=\"_blank\" href=\"https:\/\/icecure-medical.com\/us\/prosense-system\/\" rel=\"nofollow noopener noreferrer\">ProSense\u00ae<\/a>, and proposed indication for use, including for use in the treatment of patients with T1 invasive breast cancer and\/or patients not suitable for surgical alternatives for the treatment of breast cancer. ProSense\u00ae is a liquid-nitrogen-based cryoablation system that enables minimally-invasive, treatment of cancer tumors. <\/p>\n<p>The FDA Breakthrough Device Program is intended to help patients receive more timely access to medical devices that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions. Under the program, the FDA will provide a priority review and feedback through development to commercialization. IceCure looks forward to this accelerated collaborative dialogue with the FDA to expedite the commercialization of ProSense\u00ae for the treatment of benign and malignant tumors.<\/p>\n<p>\n        <span class=\"xn-person\">Eyal Shamir<\/span>, Chief Executive Officer of IceCure commented, &#8220;We are thrilled to receive the Breakthrough Device Designation from the FDA for our lead asset, ProSense\u00ae, based on promising clinical outcomes in multiple clinical studies to date. ProSense\u00ae\u00a0has successfully demonstrated the potential to be an exceptionally safe and effective minimally-invasive cryoablation approach to tumor destruction. We believe receipt of this designation is a testimony to the potential of ProSense\u00ae\u00a0to become the new gold standard for cryoablation tumor therapy.&#8221;<\/p>\n<p>Mr. Shamir continued, &#8220;The addition of the Breakthrough Device Designation builds on a series of successful regulatory milestones. ProSense\u00ae\u00a0has already received FDA approval for general minimally-invasive cryoablation applications, including for kidney, liver, and benign breast tumors. IceCure is further pursuing FDA-specific approval for breast cancer with its ongoing ICE3 clinical trial, the largest controlled multilocation clinical trial in the U.S. for liquid nitrogen-based cryoablation of small, low-risk, early-stage malignant breast tumors. We are excited to have updated interim results of the ICE3 trial presented at the upcoming <a target=\"_blank\" href=\"https:\/\/www.breastsurgeons.org\/meeting\/2021\/\" rel=\"nofollow noopener noreferrer\">American Society of Breast Surgeons Annual Meeting<\/a> on <span class=\"xn-chron\">April 30<\/span>.&#8221; <\/p>\n<p>&#8220;As we continue to evaluate ProSense\u00ae for the treatment of breast cancer tumors in our ICE3 clinical trial, we are grateful to the FDA&#8217;s Breakthrough Device Program. The FDA&#8217;s rapid approval process combined with its extensive feedback, leaves IceCure well-positioned for an expedited path towards breast cancer commercialization in the U.S.\u00a0We are looking forward to continuing to work closely with the FDA to make ProSense\u00ae\u00a0available to the breast cancer patients that can benefit from our minimally-invasive cryoablation solution,&#8221; concluded Mr. Shamir.<\/p>\n<p>As part of the Breakthrough Device Program, the <a target=\"_blank\" href=\"https:\/\/www.federalregister.gov\/documents\/2020\/09\/01\/2020-19289\/medicare-program-medicare-coverage-of-innovative-technology-mcit-and-definition-of-reasonable-and\" rel=\"nofollow noopener noreferrer\">Medicare Coverage of Innovative Technology (MCIT) program<\/a>, which is pending approval by the Biden Administration, could provide national Medicare coverage for breakthrough-designated devices, such as the ProSense\u00ae, for a four-year duration starting on the day of the FDA marketing authorization. The Company will still be required to apply for CPT1 codes under regular approval procedures in order to receive reimbursement after the four-year provisional coverage period. <\/p>\n<p>\n        <b>About IceCure Medical<\/b>\n      <\/p>\n<p>Founded in 2006, <span class=\"xn-location\">Israel<\/span>-based IceCure Medical (TASE: ICCM), develops and markets an advanced liquid-nitrogen-based cryoablation therapy for the treatment of tumors (benign and cancerous) by freezing, with the primary focus areas being breast, kidney, bone and lung cancer. Its minimally-invasive technology is a safe and effective surgical alternative to tumor removal that is easily performed in a relatively short procedure. The system is marketed and sold worldwide, after receiving FDA and CE approvals. To learn more, please visit: <a target=\"_blank\" href=\"http:\/\/www.icecure-medical.com\/\" rel=\"nofollow noopener noreferrer\">www.icecure-medical.com<\/a>.<\/p>\n<p>\n        <b>Forward Looking Statements <\/b>\n      <\/p>\n<p>The foregoing about completing the Transaction is Forward-Looking Information, as defined in the Securities Law, which depends on factors outside the Company&#8217;s control, including the General Meeting&#8217;s approval of the Transaction and receiving TASE&#8217;s approval to list the securities for trading. In addition, the statements about listing the Company shares for trading on NASDAQ without the need for a concurrent public offering depend on factors that are outside the Company&#8217;s control, including the Company meeting NASDAQ rules and provisions at the time of listing, market conditions, receiving the SEC&#8217;s approval for the listing document and the document&#8217;s entry into effect. In view of the foregoing, this information might not materialize or materialize significantly differently than described above.<\/p>\n<p>\n        <b>Communication Contact:<\/b>\n      <\/p>\n<p>Tlalit Bussi Tel Tzure<br \/>VP BD &amp; Marketing<br \/>IceCure Medical Ltd<br \/>972.54.565.0737<br \/><a target=\"_blank\" href=\"mailto:tlalitb@icecure-medical.com\" rel=\"nofollow noopener noreferrer\">tlalitb@icecure-medical.com<\/a><\/p>\n<p>\n        <b>IR Contact:<br \/><\/b><br \/>\n        <span class=\"xn-person\">Jeremy Feffer<\/span><br \/>\n        <br \/>T: 212.915.2568 | M: 917.749.1494<br \/><a target=\"_blank\" href=\"mailto:jeremy@lifesciadvisors.com\" rel=\"nofollow noopener noreferrer\">jeremy@lifesciadvisors.com<\/a><\/p>\n<p>\u00a0<\/p>\n<p id=\"PURL\">\n        <img loading=\"lazy\" decoding=\"async\" title=\"Cision\" width=\"12\" height=\"12\" alt=\"Cision\" src=\"https:\/\/c212.net\/c\/img\/favicon.png?sn=IO31797&amp;sd=2021-04-05\" \/> View original content:<a id=\"PRNURL\" rel=\"nofollow\" href=\"http:\/\/www.prnewswire.com\/news-releases\/icecure-medical-granted-fda-breakthrough-device-designation-for-prosense-cryoablation-system-301261926.html\">http:\/\/www.prnewswire.com\/news-releases\/icecure-medical-granted-fda-breakthrough-device-designation-for-prosense-cryoablation-system-301261926.html<\/a><\/p>\n<p>SOURCE  IceCure Medical<\/p>\n<\/p><\/div>\n<p>    <img decoding=\"async\" alt=\"\" src=\"https:\/\/rt.prnewswire.com\/rt.gif?NewsItemId=IO31797&amp;Transmission_Id=202104050800PR_NEWS_USPR_____IO31797&amp;DateId=20210405\" style=\"border:0px;width:1px;height:1px\" \/><\/p>\n","protected":false},"excerpt":{"rendered":"<p>&#8211; Treatment for patients with T1 invasive breast cancer and\/or breast cancer for patients not suitable for surgical alternatives included in the indications being reviewed PR Newswire CAESAREA, Israel, April 5, 2021 \/PRNewswire\/ &#8212;\u00a0IceCure Medical Ltd. (TASE: ICCM) (&#8220;IceCure&#8221; or the &#8220;Company&#8221;), developer of the next generation cryoablation technology that destroys tumors by freezing, announced today that it has been granted Designation as a Breakthrough Device from the U.S. Food and Drug Administration (FDA) for its lead asset, ProSense\u00ae, and proposed indication for use, including for use in the treatment of patients with T1 invasive breast cancer and\/or patients not suitable for surgical alternatives for the treatment of breast cancer. ProSense\u00ae is a liquid-nitrogen-based cryoablation system that enables minimally-invasive, treatment &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/icecure-medical-granted-fda-breakthrough-device-designation-for-prosense-cryoablation-system\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;IceCure Medical Granted FDA Breakthrough Device Designation for ProSense\u00ae Cryoablation System&#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-470731","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>IceCure Medical Granted FDA Breakthrough Device Designation for ProSense\u00ae Cryoablation System - 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\/icecure-medical-granted-fda-breakthrough-device-designation-for-prosense-cryoablation-system\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"IceCure Medical Granted FDA Breakthrough Device Designation for ProSense\u00ae Cryoablation System - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"&#8211; Treatment for patients with T1 invasive breast cancer and\/or breast cancer for patients not suitable for surgical alternatives included in the indications being reviewed PR Newswire CAESAREA, Israel, April 5, 2021 \/PRNewswire\/ &#8212;\u00a0IceCure Medical Ltd. (TASE: ICCM) (&#8220;IceCure&#8221; or the &#8220;Company&#8221;), developer of the next generation cryoablation technology that destroys tumors by freezing, announced today that it has been granted Designation as a Breakthrough Device from the U.S. Food and Drug Administration (FDA) for its lead asset, ProSense\u00ae, and proposed indication for use, including for use in the treatment of patients with T1 invasive breast cancer and\/or patients not suitable for surgical alternatives for the treatment of breast cancer. ProSense\u00ae is a liquid-nitrogen-based cryoablation system that enables minimally-invasive, treatment &hellip; Continue reading &quot;IceCure Medical Granted FDA Breakthrough Device Designation for ProSense\u00ae Cryoablation System&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/icecure-medical-granted-fda-breakthrough-device-designation-for-prosense-cryoablation-system\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2021-04-05T12:04:31+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/c212.net\/c\/img\/favicon.png?sn=IO31797&amp;sd=2021-04-05\" \/>\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\\\/icecure-medical-granted-fda-breakthrough-device-designation-for-prosense-cryoablation-system\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/icecure-medical-granted-fda-breakthrough-device-designation-for-prosense-cryoablation-system\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"IceCure Medical Granted FDA Breakthrough Device Designation for ProSense\u00ae Cryoablation System\",\"datePublished\":\"2021-04-05T12:04:31+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/icecure-medical-granted-fda-breakthrough-device-designation-for-prosense-cryoablation-system\\\/\"},\"wordCount\":787,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/icecure-medical-granted-fda-breakthrough-device-designation-for-prosense-cryoablation-system\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/c212.net\\\/c\\\/img\\\/favicon.png?sn=IO31797&amp;sd=2021-04-05\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/icecure-medical-granted-fda-breakthrough-device-designation-for-prosense-cryoablation-system\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/icecure-medical-granted-fda-breakthrough-device-designation-for-prosense-cryoablation-system\\\/\",\"name\":\"IceCure Medical Granted FDA Breakthrough Device Designation for ProSense\u00ae Cryoablation System - 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(TASE: ICCM) (&#8220;IceCure&#8221; or the &#8220;Company&#8221;), developer of the next generation cryoablation technology that destroys tumors by freezing, announced today that it has been granted Designation as a Breakthrough Device from the U.S. Food and Drug Administration (FDA) for its lead asset, ProSense\u00ae, and proposed indication for use, including for use in the treatment of patients with T1 invasive breast cancer and\/or patients not suitable for surgical alternatives for the treatment of breast cancer. ProSense\u00ae is a liquid-nitrogen-based cryoablation system that enables minimally-invasive, treatment &hellip; Continue reading \"IceCure Medical Granted FDA Breakthrough Device Designation for ProSense\u00ae Cryoablation System\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/icecure-medical-granted-fda-breakthrough-device-designation-for-prosense-cryoablation-system\/","og_site_name":"Market Newsdesk","article_published_time":"2021-04-05T12:04:31+00:00","og_image":[{"url":"https:\/\/c212.net\/c\/img\/favicon.png?sn=IO31797&amp;sd=2021-04-05","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"4 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/icecure-medical-granted-fda-breakthrough-device-designation-for-prosense-cryoablation-system\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/icecure-medical-granted-fda-breakthrough-device-designation-for-prosense-cryoablation-system\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"IceCure Medical Granted FDA Breakthrough Device Designation for ProSense\u00ae Cryoablation System","datePublished":"2021-04-05T12:04:31+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/icecure-medical-granted-fda-breakthrough-device-designation-for-prosense-cryoablation-system\/"},"wordCount":787,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/icecure-medical-granted-fda-breakthrough-device-designation-for-prosense-cryoablation-system\/#primaryimage"},"thumbnailUrl":"https:\/\/c212.net\/c\/img\/favicon.png?sn=IO31797&amp;sd=2021-04-05","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/icecure-medical-granted-fda-breakthrough-device-designation-for-prosense-cryoablation-system\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/icecure-medical-granted-fda-breakthrough-device-designation-for-prosense-cryoablation-system\/","name":"IceCure Medical Granted FDA Breakthrough Device Designation for ProSense\u00ae Cryoablation System - 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