{"id":412790,"date":"2021-01-12T07:03:36","date_gmt":"2021-01-12T12:03:36","guid":{"rendered":"http:\/\/www.marketnewsdesk.com\/?p=412790"},"modified":"2021-01-12T07:03:36","modified_gmt":"2021-01-12T12:03:36","slug":"health-canada-authorizes-cytosorb-for-use-in-hospitalized-covid-19-patients-2","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/health-canada-authorizes-cytosorb-for-use-in-hospitalized-covid-19-patients-2\/","title":{"rendered":"Health Canada Authorizes CytoSorb for Use in Hospitalized COVID-19 Patients"},"content":{"rendered":"
\n

PR Newswire<\/p>\n<\/p><\/div>\n

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\n CytoSorb now immediately commercially available throughout North America<\/span> for use in COVID-19 patients, and in a total of 67 countries worldwide<\/i>\n <\/p>\n

\n MONMOUTH JUNCTION, N.J.<\/span>, Jan. 12, 2021<\/span> \/PRNewswire\/ —\u00a0CytoSorbents Corporation<\/a>\u00a0(NASDAQ: CTSO), a critical care immunotherapy leader commercializing its CytoSorb\u00ae<\/a>\u00a0blood purification technology to treat deadly inflammation in critically ill and cardiac surgery patients around the world, announces that Health Canada<\/span><\/a>\u00a0has granted Medical Device Authorization for the importation, sale, and emergency use of CytoSorb in hospitalized COVID-19 patients under Interim Order (IO) ID# 316575<\/a>.\u00a0 CytoSorbents will collaborate with ebbtides medical<\/a>, a specialty distributor of medical products throughout Canada<\/span>, to ensure rapid and widespread availability of the therapy.<\/p>\n

\n

\n
\n \"CytoSorbents
\n <\/a>\n <\/p>\n<\/p><\/div>\n

Mr. Steve Tymchuk<\/span>, President and CEO of ebbtides medical<\/a>\u00a0stated, “ebbtides medical is a well-established company located in Vancouver<\/span>, with over 15 years of experience in the medical\/surgical industry providing excellent solutions to the healthcare market, specializing in extracorporeal life support and cardiac surgery.\u00a0 We are excited to work with CytoSorbents to make CytoSorb immediately available during the COVID-19 crisis in Canada<\/span> under Health Canada’s COVID-19 Medical Device Authorization for Importation and Sale.”<\/p>\n

Mr.\u00a0Vincent Capponi, President and Chief Operating Officer of CytoSorbents stated, “We have worked closely with Health Canada and our new Canadian distributor, ebbtides medical, to achieve this special COVID-19 authorization.\u00a0 We are pleased to note that CytoSorb is now approved throughout North America<\/span> for use in COVID-19 patients, and now commercially available in 67 countries worldwide.\u00a0 Cases of COVID-19 have been steadily rising in Canada<\/span>, with approximately 600,000 confirmed cases<\/a>\u00a0already.\u00a0 Last month marked our first shipments of CytoSorb into Canada<\/span> and we plan to work closely with ebbtides medical to deploy CytoSorb in hospitals throughout Canada<\/span> to help as many patients as possible, particularly as most of the world waits for the COVID-19 vaccine.\u00a0 We believe the broad usage of CytoSorb, and multiple approvals and COVID-19 authorizations around the world speak to the value of our therapy in helping to treat deadly inflammatory illnesses such as COVID-19 and many others.”<\/p>\n

An Interim Order<\/a>\u00a0is one of the fastest mechanisms available to the Canadian government to help make health products available to address larger-scale public health emergencies, such as the COVID-19 pandemic.\u00a0 The current authorization is only valid as long as the IO is in effect. The IO is currently in effect\u00a0until Fall of 2021<\/a><\/u>, but may be renewed based on the ongoing public health need.\u00a0 CytoSorb received U.S. FDA Emergency Use Authorization (EUA) in April 2020<\/span><\/a>, and achieved marketing approval in Mexico<\/span><\/a>\u00a0in March 2020<\/span> as a broad extracorporeal cytokine adsorber for use in a wide variety of critical illnesses and cardiac surgery.<\/p>\n

\n About ebbtides medical<\/b>\n <\/p>\n

With over 15 years of experience in the medical\/surgical industry, ebbtides medical<\/a> is a well-respected distributor of cardiac products that serve to enhance surgical outcomes within Canada<\/span>. While others profess to excel at customer service, ebbtides perpetually strives to exceed customer expectations\u2026as steady as the ebb tide.\u00a0 For more information, see www.ebbtidesmedical.com<\/a><\/p>\n

\n About CytoSorbents Corporation (<\/b>
\n
\n NASDAQ:\u00a0CTSO<\/a>
\n <\/b>
\n )<\/b>\n <\/p>\n

\n CytoSorbents Corporation<\/a>\u00a0is a leader in critical care immunotherapy, specializing in blood purification. Its flagship product, CytoSorb\u00ae<\/a> is approved in the European Union with distribution in 67 countries around the world, as an extracorporeal cytokine adsorber designed to reduce the “cytokine storm” or “cytokine release syndrome” that could otherwise cause massive inflammation, organ failure and death in common critical illnesses. These are conditions where the risk of death is extremely high, yet no effective treatments exist. CytoSorb\u00ae<\/a> is also being used during and after cardiac surgery to remove inflammatory mediators that can lead to post-operative complications, including multiple organ failure. CytoSorb\u00ae has been used in more than 110,000 human treatments to date.\u00a0 CytoSorb has received CE-Mark label expansions for the removal of bilirubin (liver disease), myoglobin (trauma) and both ticagrelor<\/a> and rivaroxaban<\/a> during cardiothoracic surgery.\u00a0 CytoSorb has also received FDA Emergency Use Authorization<\/a> in the United States<\/span> for use in critically ill COVID-19 patients with imminent or confirmed respiratory failure, in defined circumstances.\u00a0 CytoSorb has also been granted FDA Breakthrough Designation<\/a> for the removal of ticagrelor in a cardiopulmonary bypass circuit during emergent and urgent cardiothoracic surgery.<\/p>\n

CytoSorbents’ purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface adsorption. Its technologies have received non-dilutive grant, contract, and other funding of more than $38 million<\/span> from DARPA, the U.S. Department of Health and Human Services (HHS), the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), the U.S. Army, the U.S. Air Force, U.S. Special Operations Command (SOCOM), Air Force Material Command (USAF\/AFMC), and others. The Company has numerous products under development based upon this unique blood purification technology protected by many issued U.S. and international patents and multiple applications pending, including ECOS-300CY\u2122, CytoSorb-XL\u2122, HemoDefend-RBC\u2122, HemoDefend-BGA\u2122, VetResQ\u2122, K+<\/sup>ontrol\u2122, ContrastSorb, DrugSorb, and others.\u00a0 \u00a0\u00a0For more information, please visit the Company’s websites at www.cytosorbents.com<\/a> and www.cytosorb.com<\/a> or follow us on Facebook<\/a> and Twitter<\/a>.<\/p>\n

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

This press release includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about our plans, objectives, representations and contentions,\u00a0including statements regarding our expectations about our cash runway, the advancement of our trials, our plans to initiate new trials, our goals to develop and commercialize CytoSorb and the timing thereof, the potential impact of COVID-19 on our operations and milestones,\u00a0 and are not historical facts and typically are identified by use of terms such as “may,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue” and similar words, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements in this press release represent management’s current judgment and expectations, but our actual results, events and performance could differ materially from those in the forward-looking statements. Factors which could cause or contribute to such differences include, but are not limited to, risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 5, 2020<\/span>, as updated by the risks reported in our Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K, and in the press releases and other communications to shareholders issued by us from time to time which attempt to advise interested parties of the risks and factors which may affect our business. We caution you not to place undue reliance upon any such forward-looking statements, particularly in light of the current coronavirus pandemic, where businesses can be impacted by rapidly changing state and federal regulations, as well as the health and availability of their workforce. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, other than as required under the Federal securities laws.<\/p>\n

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\n Cytosorbents Contact:
<\/b>
\n Amy Vogel<\/span>
\n
Investor Relations
732-398-5394
avogel@cytosorbents.com<\/a><\/p>\n

\n Investor Relations Contact:
<\/b>
\n Jeremy Feffer<\/span>
\n
LifeSci Advisors
917-749-1494
jeremy@lifesciadvisors.com<\/a> \u00a0<\/p>\n

\n Public Relations Contact:
<\/b>
\n Eric Kim<\/span>
\n
Rubenstein Public Relations
212-805-3055
ekim@rubensteinpr.com<\/a><\/p>\n

\u00a0<\/p>\n

<\/div>\n

\n \"Cision\" View original content to download multimedia:http:\/\/www.prnewswire.com\/news-releases\/health-canada-authorizes-cytosorb-for-use-in-hospitalized-covid-19-patients-301206034.html<\/a><\/p>\n

SOURCE CytoSorbents Corporation<\/p>\n<\/p><\/div>\n

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

PR Newswire CytoSorb now immediately commercially available throughout North America for use in COVID-19 patients, and in a total of 67 countries worldwide MONMOUTH JUNCTION, N.J., Jan. 12, 2021 \/PRNewswire\/ —\u00a0CytoSorbents Corporation\u00a0(NASDAQ: CTSO), a critical care immunotherapy leader commercializing its CytoSorb\u00ae\u00a0blood purification technology to treat deadly inflammation in critically ill and cardiac surgery patients around the world, announces that Health Canada\u00a0has granted Medical Device Authorization for the importation, sale, and emergency use of CytoSorb in hospitalized COVID-19 patients under Interim Order (IO) ID# 316575.\u00a0 CytoSorbents will collaborate with ebbtides medical, a specialty distributor of medical products throughout Canada, to ensure rapid and widespread availability of the therapy. Mr. Steve Tymchuk, President and CEO of ebbtides medical\u00a0stated, “ebbtides medical is a … <\/p>\n

Continue reading “Health Canada Authorizes CytoSorb for Use in Hospitalized COVID-19 Patients”<\/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-412790","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nHealth Canada Authorizes CytoSorb for Use in Hospitalized COVID-19 Patients - 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\/health-canada-authorizes-cytosorb-for-use-in-hospitalized-covid-19-patients-2\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Health Canada Authorizes CytoSorb for Use in Hospitalized COVID-19 Patients - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"PR Newswire CytoSorb now immediately commercially available throughout North America for use in COVID-19 patients, and in a total of 67 countries worldwide MONMOUTH JUNCTION, N.J., Jan. 12, 2021 \/PRNewswire\/ —\u00a0CytoSorbents Corporation\u00a0(NASDAQ: CTSO), a critical care immunotherapy leader commercializing its CytoSorb\u00ae\u00a0blood purification technology to treat deadly inflammation in critically ill and cardiac surgery patients around the world, announces that Health Canada\u00a0has granted Medical Device Authorization for the importation, sale, and emergency use of CytoSorb in hospitalized COVID-19 patients under Interim Order (IO) ID# 316575.\u00a0 CytoSorbents will collaborate with ebbtides medical, a specialty distributor of medical products throughout Canada, to ensure rapid and widespread availability of the therapy. 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Mr. Steve Tymchuk, President and CEO of ebbtides medical\u00a0stated, “ebbtides medical is a … Continue reading \"Health Canada Authorizes CytoSorb for Use in Hospitalized COVID-19 Patients\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/health-canada-authorizes-cytosorb-for-use-in-hospitalized-covid-19-patients-2\/","og_site_name":"Market Newsdesk","article_published_time":"2021-01-12T12:03:36+00:00","og_image":[{"url":"https:\/\/mma.prnewswire.com\/media\/1096384\/CytoSorbents_Working_To_Save_Lives_Logo.jpg","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"6 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/health-canada-authorizes-cytosorb-for-use-in-hospitalized-covid-19-patients-2\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/health-canada-authorizes-cytosorb-for-use-in-hospitalized-covid-19-patients-2\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"Health Canada Authorizes CytoSorb for Use in Hospitalized COVID-19 Patients","datePublished":"2021-01-12T12:03:36+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/health-canada-authorizes-cytosorb-for-use-in-hospitalized-covid-19-patients-2\/"},"wordCount":1218,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/health-canada-authorizes-cytosorb-for-use-in-hospitalized-covid-19-patients-2\/#primaryimage"},"thumbnailUrl":"https:\/\/mma.prnewswire.com\/media\/1096384\/CytoSorbents_Working_To_Save_Lives_Logo.jpg","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/health-canada-authorizes-cytosorb-for-use-in-hospitalized-covid-19-patients-2\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/health-canada-authorizes-cytosorb-for-use-in-hospitalized-covid-19-patients-2\/","name":"Health Canada Authorizes CytoSorb for Use in Hospitalized COVID-19 Patients - 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