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CytoSorbents Awarded $2,897,172 Phase III STTR Contract to Advance HemoDefend-BGA Plasma and Whole Blood Filter to Clinical Trials

Key Takeaway: CytoSorbents Awarded $2,897,172 Phase III STTR Contract to Advance HemoDefend-BGA Plasma and Whole Blood Filter to Clinical Trials MONMOUTH JUNCTION, N.J., June 9, 2020 - CytoSorbents Corporation (NASDAQ:CTSO), a critical care immunotherapy leader specializing in blood purific

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CytoSorbents Awarded $2,897,172 Phase
III STTR Contract to Advance HemoDefend-BGA Plasma and Whole Blood Filter to Clinical Trials
MONMOUTH JUNCTION, N.J., June 9, 2020 -
CytoSorbents Corporation (NASDAQ:CTSO), a critical care immunotherapy leader specializing in blood purification, announced today
that it was awarded a Defense Health Agency Small Business Technology Transfer (STTR) Phase III contract, valued at up to $2,897,172
over 2 years, to advance its HemoDefend-BGA plasma and whole blood adsorber to human clinical trials. The program, entitled "Development
of a Highly Efficient Adsorber to Remove Anti-A and Anti-B Antibodies from Blood and Plasma for Transfusion," is being funded
by the U.S. Army Medical Research and Development Command (USAMRDC) office of the Congressionally Directed Medical Research Programs
(CDMRP). This follows the successful completion of Phase I and II STTR contracts of approximately $1.15 million with researchers
at Penn State University, previously funded by the U.S. Army Medical Research Acquisition Activity (USAMRAA) and the U.S. Army
Medical Research and Material Command (USAMRMC).
Plasma and whole blood are life-saving
blood products, particularly in civilian and combat trauma where the loss of blood, or hemorrhage, is the leading cause of preventable
deaths. However, these products have limitations due to the presence of anti-A and anti-B antibodies in the blood plasma that can
cause hemolytic transfusion reactions in an incompatible recipient.
The HemoDefend-BGA filter is part of the
HemoDefend family of blood transfusion filters, and is fundamentally different from the HemoDefend-RBC filter for packed
red blood cells. The HemoDefend-BGA filter is designed to enable "universal plasma", or plasma that can be administered
to anyone regardless of blood type, and to improve the safety of whole blood transfusions, by the rapid and efficient removal of
anti-A and anti-B antibodies from these two blood products. An advanced HemoDefend-BGA prototype was developed previously under
the prior STTR Phase II program.
Dr. Maryann Gruda, PhD, Principal Investigator
and Director of Biology of CytoSorbents stated, "We are excited to take this next major step in the development of the HemoDefend-BGA
adsorber. A tremendous amount of effort and innovation has gone into the current prototype that has exceeded program performance
expectations. With this new funding, we plan to optimize our prototype and scale-up manufacturing to produce commercial-grade materials.
This will facilitate advancement of the HemoDefend-BGA adsorber through pre-clinical testing to human clinical trials, with the
goal of potential U.S. FDA regulatory approval. If successful, we expect the HemoDefend-BGA adsorber to expand the availability
of universal plasma and whole blood that may help to save warfighter and civilian lives."
Dr. Phillip Chan, MD, PhD, Chief Executive
Officer of CytoSorbents stated, "The development of a simple device that efficiently reduces the level of anti-A and anti-B
antibodies in whole blood and plasma to low titer is a major milestone in our collaboration with the U.S. military. We are grateful
for U.S. Army support and proud to contribute to this important program. We plan to work aggressively to make this technology commercially
available as soon as possible."
the straw-colored, cell-free portion of whole blood. It contains a wide range of important substances such as electrolytes, hormones,
proteins such as albumin, clotting factors, and antibodies. The transfusion of plasma, or plasma-derived products, is used widely
to help save the lives of trauma and bleeding victims, septic and other critically-ill patients, and patients with life-threatening
blood coagulation and autoimmune disorders. In 2017, approximately 3.0 million units of plasma were distributed in the United
States alone. Most plasma contains blood-type specific antibodies and must be cross-matched for blood
type with the intended recipient ahead of time or risk serious transfusion reactions. The only "universal" plasma is
Type AB plasma, which lack anti-A and anti-B antibodies, but is rare, accounting for less than 5.0% of potential donors. By reducing
these blood-type specific antibodies from donated plasma of all blood types, the goal is to create a cost-effective, reliable,
and expanded source of "universal" plasma that can be administered immediately, without blood-typing, in a wide range
of emergent and non-emergent situations.
Many studies have demonstrated that whole
blood transfusion is superior in hemorrhage control and survival in severe trauma, compared to individual blood component transfusions
(e.g. pRBCs, platelets, plasma). In the military, in emergency or mass casualty situations when the demand for refrigerated blood
products has exceeded the supply inventory in the combat zone, the "Walking Blood Bank" program can be implemented,
where unwounded soldiers can donate their blood to those that have fallen. Type O whole blood is typically the universal donor
type, but since it is roughly 60% plasma, anti-A and anti-B antibodies can be present at various levels that can cause potentially
fatal hemolytic transfusion reactions in the recipient. Currently, the military relies on pre-screening and identification of low
titer Type O donors. By removing these antibodies from whole blood, HemoDefend-BGA may help to improve the safety of whole blood
transfusion across all blood types and make the logistics of treatment much easier.
The HemoDefend-BGA Adsorber is not yet
approved in the U.S. or elsewhere. This Award is supported by the Defense Health Agency STTR Program/U.S. Army Medical Research
and Development Command (USAMRDC)/Congressionally Directed Medical Research Program (CDMRP) under Contract No. W81XWH-20-C-0050.
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 U.S. Army Medical Research and Development Command (USAMRDC) or the U.S. Army Medical Research Acquisition
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 88,000 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. 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 approximately
$33 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), Air Force Material Command (USAF/AFMC),
Joint Program Executive Office for Chemical Biological Defense (JPEO-CBD), 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
Forward-Looking Statements
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"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
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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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Last updated: Jun 9, 2020