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U.S. FDA GRANTS CYTOSORB® EMERGENCY USE AUTHORIZATION FOR USE IN PATIENTS WITH
COVID-19 INFECTION
USA - ENGLISH
* FRANCE - FRANÇAIS
* DEUTSCHLAND - DEUTSCH
* NEDERLAND - NEDERLANDS
--------------------------------------------------------------------------------
News provided by
CytoSorbents Corporation
Apr 13, 2020, 07:43 ET
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MONMOUTH JUNCTION, N.J., April 13, 2020 /PRNewswire/ -- CytoSorbents
Corporation (NASDAQ: CTSO), a critical care immunotherapy leader
commercializing its CytoSorb® blood purification technology to treat cytokine
storm and deadly inflammation in critically-ill and cardiac surgery patients
around the world, announced the United States Food and Drug Administration (FDA)
has granted Emergency Use Authorization (EUA) of CytoSorb® for use in patients
with COVID-19 infection.
Under the EUA, CytoSorbents can make CytoSorb available, through commercial
sales, to all hospitals in the United States for use in patients, 18 years of
age or older, with confirmed COVID-19 infection who are admitted to the
intensive care unit (ICU) with confirmed or imminent respiratory failure who
have early acute lung injury or acute respiratory distress syndrome (ARDS),
severe disease, or life-threatening illness resulting in respiratory failure,
septic shock, and/or multiple organ dysfunction or failure, as described in
FDA's authorization and as detailed below.
Patients with COVID-19 infection often exhibit a cytokine storm with severe
hyperinflammation that can contribute to worsened injury to vital organs like
the lungs, heart, and the kidneys. The goal of CytoSorb therapy is to reduce
cytokine storm and the deadly inflammatory response through blood purification
so that this injury may be mitigated or prevented. CytoSorb is plug-and-play
compatible with the most commonly used blood purification machines or pumps in
the intensive care unit used to treat COVID-19 patients, including
hemoperfusion, hemodialysis, continuous renal replacement therapy (CRRT), and
extracorporeal membrane oxygenation (ECMO) machines.
Mr. Vincent Capponi, Chief Operating Officer of CytoSorbents commented, "We
greatly appreciate the FDA's recognition, through this EUA, of the potential of
CytoSorb and extracorporeal blood purification to help patients stricken with
this terrible illness. It was clear in this truly collaborative process with
the FDA, that the Agency was committed to urgently providing physicians and
patients with new treatment options in the fight against COVID-19. We plan to
continue working with the FDA to help as many patients as possible."
Dr. Phillip Chan, MD, PhD, Chief Executive Officer of CytoSorbents stated, "As a
U.S. based company with CytoSorb device manufacturing in New Jersey, we are
eager to expand the availability of CytoSorb to U.S. hospitals and patients as a
treatment option to fight cytokine storm and deadly inflammation that is
believed to exacerbate COVID-19 infection. With more than 555,000 documented
coronavirus infections, the U.S. leads the world with over 22,000 deaths, and
emergently needs new therapies to reduce the severity of this disease. This is
important not just to reduce poor clinical outcomes and mortality, but to also
alleviate the bottleneck for scarce resources such as ventilators and ECMO in
the treatment of these critically-ill patients."
Dr. Chan continued, "CytoSorb has been used in critically-ill and cardiac
surgery patients in more than 80,000 human treatments abroad, to help treat the
same complications seen in COVID-19 patients such as lung failure, shock, and
multi-organ failure. With CRRT, and in many cases ECMO, being standard in ICUs
worldwide, CytoSorb can be easily implemented with minimal training. More than
200 COVID-19 patients have been treated with CytoSorb outside the U.S.,
resulting in the inclusion of CytoSorb into the COVID-19 treatment guidelines in
Italy, Panama, and China. We have now received more than 70 requests from major
U.S. hospitals to use CytoSorb in COVID-19 patients. Under the EUA, we plan to
ramp the availability of CytoSorb in a controlled manner, to clinical centers
that will work with us to generate data and leverage our knowledge of how to use
the device most effectively. We are pleased to collaborate with the FDA to make
this possible."
According to the EUA letter from the FDA, "There are no FDA approved, licensed,
or cleared device treatments for COVID-19. Based on bench performance testing
and reported clinical experience, FDA has concluded that the CytoSorb device may
be effective at treating certain patients with confirmed COVID-19 by removing
various pro-inflammatory cytokines from their blood. FDA believes, based on the
totality of scientific evidence available, that the removal of pro-inflammatory
cytokines may ameliorate cytokine storm due to the overabundance of
pro-inflammatory cytokines and, in turn, provide clinical benefit," adding that
"It is reasonable to believe that the CytoSorb device may be effective in
treating patients 18 years of age or older with confirmed COVID-19 admitted to
the ICU with confirmed or imminent respiratory failure, when used consistently
with the Scope of Authorization of this letter."
As referenced in the EUA letter, CytoSorb can be used on patients 18 years of
age or older, with confirmed COVID-19 who are admitted to the ICU with confirmed
or imminent respiratory failure who have any one of the following conditions:
a) Early acute lung injury (ALI)/early acute respiratory distress syndrome
(ARDS); or
b) Severe disease, defined as:
1) dyspnea,
2) respiratory frequency ≥ 30/min,
3) blood oxygen saturation ≤ 93%,
4) partial pressure of arterial oxygen to fraction of inspired oxygen
ratio < 300, and/or
5) lung infiltrates > 50% within 24 to 48 hours; or
c) Life-threatening disease, defined as:
1) respiratory failure,
2) septic shock, and/or
3) multiple organ dysfunction or failure.
The CytoSorb device has been authorized by FDA under an EUA. It has neither been
cleared nor approved for the indication to treat patients with COVID-19
Infection. The EUA will be effective until the declaration, that circumstances
exist justifying the authorization of the emergency use of the CytoSorb device
during the COVID-19 pandemic, is terminated under section 564(B)(2) of the Act,
or the EUA is revoked under section 564(g) of the Act.
About FDA Emergency Use Authorization
Based on the FDA EUA website, "The Emergency Use Authorization (EUA) authority
allows FDA to help strengthen the nation's public health protections against
chemical, biological, radiological, and nuclear (CBRN) threats by facilitating
the availability and use of medical countermeasures needed during public health
emergencies. Under Section 564 of the Federal Food, Drug, and Cosmetic Act
(the "Act"), the FDA commissioner may allow unapproved medical products or
unapproved uses of approved medical products to be used in an emergency to
diagnose, treat, or prevent serious or life-threatening disease or conditions
caused by CBRN threat agents when there are no adequate, approved, and available
alternatives."
EUA is fundamentally different from the FDA's Expanded Access Program for
Medical Devices, which encompasses Emergency Use, Compassionate Use, and
Treatment Investigational Device Exemptions (IDEs), all of which are limited in
scope and, in the case of Compassionate Use and Treatment IDEs, require
specific agency approval, often on a case-by-case basis. In contrast, EUA
enables access and commercialization of therapies to hospitals nationwide, under
broader guidelines for usage.
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 58 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® has been used in more than 80,000 human treatments to date. CytoSorb
has 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.
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 nearly $29
million from DARPA, the U.S. Army, the U.S. Department of Health and Human
Services, the National Institutes of Health (NIH), National Heart, Lung, and
Blood Institute (NHLBI), U.S. Special Operations Command (SOCOM), the U.S. Army,
U.S. Special Operations Command (USSOCOM), the U.S. Air Force, 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 CytoSorb-XL™, HemoDefend™, VetResQ™, K+ontrol™, ContrastSorb,
DrugSorb, and others. For more information, please visit the Company's websites
at www.cytosorbents.com and www.cytosorb.com or follow us on Facebook and
Twitter.
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 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, the 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 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.
Please Click to Follow Us on Facebook and Twitter
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
212-805-3052
ekim@rubensteinpr.com
SOURCE CytoSorbents Corporation
RELATED LINKS
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CYTOSORBENTS APPOINTS IRINA B. KULINETS, PHD, AS SENIOR VICE PRESIDENT OF GLOBAL
REGULATORY AFFAIRS
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CYTOSORBENTS RECEIVES $5M IN NON-DILUTIVE DEBT FINANCING FROM BRIDGE BANK AND
EXTENDS LOAN AGREEMENT
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