PRINCETON, N.J., Oct. 6, 2022
/PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO),
a critical care immunotherapy leader specializing in blood
purification, announced today that the U.S. Army Medical Research
Acquisition Activity (USAMRAA) has awarded the Company a three-year
Phase III contract valued at $4,292,641 to customize the
design of the HemoDefend-BGA™ filter for sterile integration into
collections systems for freeze-dried plasma processing to generate
freeze-dried universal plasma. 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.
CytoSorbents awarded $4.3M from U.S. DOD to enable freeze-dried
universal plasma using its HemoDefend-BGA technology
Dr. Maryann Gruda, PhD, Principal
Investigator and Senior Director of Biology at CytoSorbents stated,
"We are excited to begin this phase of our development
program. The continued support and funding of our anti-A and
anti-B blood group antibody (BGA) reduction technology by the
Defense Health Agency and U.S. Army will be instrumental in
bringing this technology to market. This award will fund the
development and scale-up of a specialized HemoDefend-BGA filter
that can be integrated with freeze-dried plasma technologies to
generate a logistically superior, low titer plasma product that can
be administered to anyone, irrespective of blood type, while
maintaining critical coagulation activity."
Dr. Phillip Chan, MD, PhD, Chief
Executive Officer of CytoSorbents stated, "Freeze-dried plasma is
dry and lightweight, stable for up to 2 years at room temperature,
and can be quickly reconstituted with sterile water when
needed. However, it currently remains a blood-type specific
product, complicating its use. HemoDefend-BGA can remove
blood-type specific antibodies from single donor or pooled plasma
prior to freeze-drying, with the goal of ultimately producing a
'one-size-fits-all' freeze-dried universal plasma – a major
advance. Such a product would also eliminate the need for
cold-chain storage – greatly simplifying battlefield logistics and
enabling first responders to provide mobile/remote emergency
resuscitation in civilian trauma."
The HemoDefend-BGA filter is not yet approved in the U.S. or
elsewhere. This award was supported by the Defense Health
Agency (DHA) Small Business Innovation Research (SBIR)/Small
Business Technology Transfer (STTR) Programs/Joint Warfighter
Medical Research Program (JWMRP) under U.S. Army Medical Research
Acquisition Activity (USAMRAA) Contract No. W81XWH-22-C-0046.
The award is entitled "Integrating Isoagglutinin Reduction for a
Universal Dried Plasma Product for Battlefield and First Responder
Use." The outcome of this award is expected to be the
large-scale manufacturing of the active polymer for subsequent
integration of the device into the plasma freeze-drying
process.
The content of this press release is solely the responsibility
of the authors and any opinions, findings, and conclusions or
recommendations expressed in this material are those of the
author(s) and do not necessarily reflect the views of the
Department of Defense, DHA, SBIR/STTR Programs, JWMRP, or
USAMRAA.
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 75
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 bodily fluids by pore capture
and surface adsorption. Its technologies have received
non-dilutive grant, contract, and other funding of approximately
$48 million 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 marketed products and
products under development based upon this unique blood
purification technology protected by many issued U.S. and
international patents and registered trademarks, and multiple
patent applications pending, 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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CytoSorbents Contact:
Kathleen Bloch
(732) 398-5429
kbloch@cytosorbents.com
U.S. Public Relations Contact:
Eric Kim
Rubenstein Public Relations
212-805-3052
ekim@rubensteinpr.com
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