PRINCETON, N.J., Sept. 9,
2022 /PRNewswire/ -- CytoSorbents Corporation
(NASDAQ: CTSO), a leader in the treatment of life-threatening
conditions in the intensive care unit and cardiac surgery using
blood purification via its proprietary polymer adsorption
technology, announced today that the U.S. Army Medical Research
Acquisition Activity, with funding from the Combat Casualty Care
Research Program, awarded the Company a two-year grant
(W81XWH-22-1-0235) valued at $1,977,024 to optimize
development of the HemoDefend-BGA™ adsorber to a fully-finished,
commercial device that will be evaluated in a pre-clinical porcine
study for safety and efficacy. This Combat Casualty Care Research
Program-funded research is a direct follow on to earlier
development work funded through the Peer Reviewed Medical Research
Program of the Congressionally Directed Medical Research
Programs.
CytoSorbents' HemoDefend-BGA program has
the potential to address a global need for universal plasma in
critical illness
The HemoDefend-BGA adsorber can rapidly remove >99% of anti-A
and anti-B antibodies from plasma to create a "universal plasma"
that could be administered to anyone, irrespective of blood type,
while maintaining critical coagulation activity. Without the need
for blood typing, widespread availability of universal plasma could
help save lives via faster emergency treatment in both civilian and
military settings.
Dr. Maryann Gruda, Principal
Investigator and Senior Director of Biology at CytoSorbents stated,
"This funding from the U.S. Army will be used to complete the
development of our anti-A and anti-B blood group antibody reduction
technology. Through prior awards, we have worked to optimize the
efficiency, robustness, and form factor of our HemoDefend-BGA
adsorber, and look forward to taking what we believe is a
transformative technology into large animal testing, where we will
evaluate the safety and efficacy of universal plasma generated by
HemoDefend-BGA. We are excited to begin this portion of the
development program."
Mr. Vincent Capponi, President
and Chief Operating Officer of CytoSorbents indicated, "Our
HemoDefend-BGA program has the potential to address a global need
for universal plasma in both civilian and combat casualty care.
This priority initiative continues to advance, benefitting from
more than $11M in government
contracts. Once the pre-clinical study and requisite benchtop
testing are successfully completed, we plan to file a U.S. FDA
pre-submission package to pursue human clinical trials with the
goal of bringing this life-saving technology to the market."
The HemoDefend-BGA Adsorber is not yet approved in the U.S. or
elsewhere. The U.S. Army Medical Research Acquisition Activity, 820
Chandler Street, Fort Detrick MD
21702-5014 is the awarding and administering acquisition office.
This award was supported by the Assistant Secretary of Defense for
Health Affairs endorsed by the U.S. Department of Defense (DoD),
through the DoD Defense Health Program (DHP), Congressionally
Directed Medical Research Programs (CDMRP), Defense Medical
Research and Development Program, Joint Program Committee 6 Combat
Casualty Care Research Program (CCCRP/JPC-6), Battlefield
Resuscitation for Immediate Stabilization of Combat Casualties
(BRISCC), in the amount of $1,977,024
under Award No. W81XWH-22-1-0235. The award is expected to optimize
development of the HemoDefend-BGA adsorber via a preclinical animal
study to evaluate safety and efficacy entitled "Demonstration of
the Safety and Efficacy of Field-Ready Blood Group Antibody (BGA)
Adsorber in a Porcine Universal Transfusion Model." The content of
this press release is solely the responsibility of the authors and
any opinions, interpretations, conclusions, or recommendations
expressed in this material are those of the author(s) and are not
necessarily endorsed by the Department of Defense.
About HemoDefend-BGA™
CytoSorbents is developing HemoDefend-BGA to enable both
universal plasma and fresh whole blood transfusions through the
reduction of anti-A and anti-B blood group antibodies via our
advanced blood purification technology. Today, plasma and whole
blood products must be carefully blood-type matched to prevent
potentially fatal hemolytic transfusion reactions in the recipient,
caused by the accidental administration of mismatched blood
products. The reduction of anti-A and anti-B antibodies could
potentially reduce or eliminate this risk, allowing for a broader
range of available donors and simplifying the transfusion process.
According to the American Red Cross, nearly 10,000 units of plasma
are needed daily in the United
States, or more than 3.5 million units a year. The World
Health Organization (WHO) reports that plasma is transfused at a
rate of 2.2 – 18.9 units per 1,000 population (median 7.7 units)
globally. In westernized countries alone, with a population of 1.5
billion, there are approximately 12 million units of plasma
administered each year. The total addressable market for
HemoDefend-BGA in transfusion medicine in westernized countries
alone is an estimated $400 million to
$600 million and represents a
fraction of the global market.
About CytoSorbents Corporation
(NASDAQ: CTSO)
CytoSorbents Corporation is a leader in the treatment of
life-threatening conditions in the intensive care unit and in
cardiac surgery through blood purification. Its lead product,
CytoSorb®, is approved in the European Union and distributed in
more than 70 countries worldwide. It is an extracorporeal cytokine
adsorber that reduces "cytokine storm" or "cytokine release
syndrome" in common critical illnesses that can lead to massive
inflammation, organ failure and patient death. In these diseases,
the risk of death can be extremely high, and there are few, if any,
effective treatments. CytoSorb is also used during and after
cardiothoracic surgery to remove inflammatory mediators that can
lead to postoperative complications, including multiple organ
failure. As of June 30, 2022, more
than 179,000 CytoSorb devices have been used cumulatively. CytoSorb
was originally launched in the European Union under CE mark as the
first cytokine adsorber. Additional CE mark extensions were granted
for bilirubin and myoglobin removal in clinical conditions such as
liver disease and trauma, respectively, and for ticagrelor and
rivaroxaban removal in cardiothoracic surgery procedures. CytoSorb
has also received FDA Emergency Use Authorization in the United States for use in adult critically
ill COVID-19 patients with impending or confirmed respiratory
failure. The DrugSorb™-ATR antithrombotic removal system, based on
the same polymer technology as CytoSorb, also received two FDA
Breakthrough Device Designations, one for the removal of
ticagrelor and another for the removal of the direct oral
anticoagulants (DOAC) apixaban and rivaroxaban in a cardiopulmonary
bypass circuit during urgent cardiothoracic procedures. The company
has initiated two FDA-approved pivotal studies to support FDA
marketing approval of DrugSorb-ATR in the
United States. The first is the randomized, controlled
STAR-T (Safe and Timely Antithrombotic Removal-Ticagrelor) study of
120 patients at 30 centers to evaluate whether intraoperative use
of DrugSorb-ATR can reduce the perioperative risk of bleeding in
patients receiving ticagrelor and undergoing cardiothoracic
surgery. The second study is the STAR‑D (Safe and Timely
Antithrombotic Removal-Direct Oral Anticoagulants) randomized,
controlled trial of 120 patients at 30 centers evaluating the
intraoperative use of DrugSorb-ATR to reduce perioperative bleeding
risk in patients undergoing cardiothoracic surgery and taking
direct oral anticoagulants, including apixaban and rivaroxaban.
CytoSorbents' purification technologies are based on
biocompatible, highly porous polymer beads that can actively remove
toxic substances from blood and other body fluids through pore
entrapment and surface adsorption. The company's technologies have
received more than $41.5 million in
non-dilutive grants, contracts and other non-dilutive funding from
DARPA, the U.S. Department of Health and Human Services (HHS), the
National Institutes of Health (NIH), the 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 marketed and
in-development products based on this unique blood purification
technology protected by numerous issued U.S. and international
patents and registered trademarks, as well as several pending
patent applications, including ECOS-300CY®,
CytoSorb-XL™, HemoDefend-RBC™, HemoDefend-BGA™,
VetResQ®, K+ontrol™, DrugSorb™,
DrugSorb™-ATR, ContrastSorb 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, future targets and outlooks
for our business, expectations regarding the future impacts of
COVID-19 or the ongoing conflict between Russia and the Ukraine, 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 10, 2022, 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. 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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Investor Relations Contact:
Amy Vogel
(732) 398-5394
avogel@cytosorbents.com
U.S. Public Relations Contact:
Eric Kim Rubenstein Public Relations
212-805-3052
ekim@rubensteinpr.com
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