Health Canada Authorizes CytoSorb for Use in Hospitalized COVID-19 Patients
CytoSorbents Corporation (NASDAQ: CTSO) announced that Health Canada has granted Medical Device Authorization for the emergency use and sale of CytoSorb in hospitalized COVID-19 patients. This authorization allows for the therapy's distribution in Canada and expands its reach to 67 countries worldwide. CytoSorbents aims to collaborate with ebbtides medical to ensure rapid availability of the treatment. The authorization is valid until Fall 2021 but may be renewed based on public health needs. CytoSorb has previously received U.S. FDA Emergency Use Authorization.
- Health Canada authorization expands CytoSorb's market access to North America and 67 countries.
- Collaboration with ebbtides medical enhances distribution capabilities in Canada.
- CytoSorb has received previous FDA Emergency Use Authorization for COVID-19 treatment.
- The authorization is only valid until Fall 2021, creating uncertainty for future availability.
- Rising COVID-19 cases in Canada indicate a growing demand for treatment, highlighting potential supply challenges.
MONMOUTH JUNCTION, N.J., Jan. 4, 2021 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO), a critical care immunotherapy leader commercializing its CytoSorb® blood purification technology to treat deadly inflammation in critically ill and cardiac surgery patients around the world, announces that Health Canada has granted Medical Device Authorization for the importation, sale, and emergency use of CytoSorb in hospitalized COVID-19 patients under Interim Order (IO) ID# 316575. 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 stated, "ebbtides medical is a well-established company located in Vancouver, 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. We are excited to work with CytoSorbents to make CytoSorb immediately available during the COVID-19 crisis in Canada under Health Canada's COVID-19 Medical Device Authorization for Importation and Sale."
Mr. Vincent 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. We are pleased to note that CytoSorb is now approved throughout North America for use in COVID-19 patients, and now commercially available in 67 countries worldwide. Cases of COVID-19 have been steadily rising in Canada, with approximately 600,000 confirmed cases already. Last month marked our first shipments of CytoSorb into Canada and we plan to work closely with ebbtides medical to deploy CytoSorb in hospitals throughout Canada to help as many patients as possible, particularly as most of the world waits for the COVID-19 vaccine. 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."
An Interim Order is 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. The current authorization is only valid as long as the IO is in effect. The IO is currently in effect until Fall of 2021, but may be renewed based on the ongoing public health need. CytoSorb received U.S. FDA Emergency Use Authorization (EUA) in April 2020, and achieved marketing approval in Mexico in March 2020 as a broad extracorporeal cytokine adsorber for use in a wide variety of critical illnesses and cardiac surgery.
About ebbtides medical
With over 15 years of experience in the medical/surgical industry, ebbtides medical is a well-respected distributor of cardiac products that serve to enhance surgical outcomes within Canada. While others profess to excel at customer service, ebbtides perpetually strives to exceed customer expectations…as steady as the ebb tide. For more information, see www.ebbtidesmedical.com
About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorbents Corporation is a leader in critical care immunotherapy, specializing in blood purification. Its flagship product, CytoSorb® 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® 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® has been used in more than 110,000 human treatments to date. CytoSorb has received CE-Mark label expansions for the removal of bilirubin (liver disease), myoglobin (trauma) and both ticagrelor and rivaroxaban during cardiothoracic surgery. CytoSorb has also received FDA Emergency Use Authorization in the United States for use in critically ill COVID-19 patients with imminent or confirmed respiratory failure, in defined circumstances. CytoSorb has also been granted FDA Breakthrough Designation for the removal of ticagrelor in a cardiopulmonary bypass circuit during emergent and urgent cardiothoracic surgery.
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
Forward-Looking Statements
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, including 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, 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, 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.
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Cytosorbents Contact:
Amy Vogel
Investor Relations
732-398-5394
avogel@cytosorbents.com
Investor Relations Contact:
Jeremy Feffer
LifeSci Advisors
917-749-1494
jeremy@lifesciadvisors.com
Public Relations Contact:
Eric Kim
Rubenstein Public Relations
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SOURCE CytoSorbents Corporation
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