MONMOUTH JUNCTION, N.J.,
Aug. 8, 2016 /PRNewswire/
-- CytoSorbents Corporation (NASDAQ: CTSO), a critical care
immunotherapy company specializing in the purification of blood and
bodily fluids, announced the award of $650,000 in funding through two separate Small
Business Innovation Research (SBIR) grant contracts by the U.S.
Army Medical Research and Materiel Command (USAMRMC) to continue
development of novel hemocompatible potassium binding polymers and
substrates that can rapidly treat life-threatening hyperkalemia in
critically-injured warfighters, civilian patients, and patients
with impaired kidney function, such as dialysis patients.
"These potassium binding polymers represent an entirely new
product category for the company. They leverage the massive
surface area of our existing hemocompatible porous polymers with
robust potassium binding technology to target rapid and sustained
potassium reduction without the need for complicated dialysis,"
said Dr. Phillip Chan, MD, PhD,
Chief Executive Officer of CytoSorbents. "Our goal is to
provide field medics with easy-to-administer solutions to acutely
treat and stabilize wounded warfighters suffering from severe
hyperkalemia as a result of massive trauma, burn injury, kidney
failure, blood transfusions, and other conditions. These
strategies could enable prolonged field care, particularly in
far-forward situations where rapid evacuation is neither safe nor
feasible. As a simpler, more rapid, and logistically friendly
alternative to dialysis, we also envision our technology being used
in emergency room or hospitalized patients with severe
hyperkalemia, and helping victims of bombings, earthquakes,
landslides and other mass casualty situations."
Hyperkalemia is defined as the excessive concentration of
potassium in the blood. Potassium is an important electrolyte
in the body that is present inside cells at high concentrations,
with the amount in blood tightly regulated. Following injury
to cells by, for example, trauma, burn injury, ischemia, or
cytotoxic drugs, such cells will continuously leak high levels of
potassium into the blood, resulting in hyperkalemia. The
kidneys normally excrete excess potassium from the blood, but when
compromised, as in critically-ill patients suffering from kidney
failure or in chronic dialysis patients with end-stage kidney
disease, the levels of blood potassium can rapidly rise
unabated. When the potassium level in the blood exceeds a
concentration of 6.0 mmol/L (normal 3.6 - 5.2 mmol/L), the risk of
heart arrhythmias and sudden cardiac death increases
significantly. Orally administered potassium sorbents such as
Kayexalate® (Sanofi-Aventis) and Veltassa® (Relypsa) are only
recommended for the non-emergent lowering of mild to moderate
hyperkalemia, while the use of insulin and glucose to drive
potassium into cells in severe hyperkalemia is only a temporary
strategy. Dialysis has been the definitive treatment of
severe hyperkalemia, but requires a large dialysis machine, an
electrical wall socket, bags of dialysate, a skilled technician,
and prolonged treatment times that are not practical in certain
situations such as far-forward or remote areas. CytoSorbents
is collaborating with leading military researchers to optimize
prototype polymers capable of rapidly reducing serum potassium in
large animal models, using simple "blood in, blood out"
hemoperfusion systems and other strategies.
Hyperkalemia is a common problem and has been reported to occur
in 1.7-5.2% of hospitalized patients in a number of studies.
It has also been recognized as a serious complication of combat
injury since World War II, when hyperkalemia and acute kidney
injury was associated with a mortality rate of 90%, and was a
leading cause of post-traumatic death in the Korean War, until the
advent of dialysis therapy. In the wars in Iraq and Afghanistan, an estimated 5.8% of all combat
casualties developed hyperkalemia within 48 hours of
injury. Even in non-crush traumatic injury, severe
hyperkalemia (>6 mmol/L) occurred in approximately 20% of
patients. Hyperkalemia was also observed in approximately 16% of
victims of natural disasters such as earthquakes, where crush
injury is common. Because of this, there is a significant
worldwide need for an easy-to-administer but effective treatment of
severe hyperkalemia. Literature references are available upon
request.
This work is supported by the U.S. Army Medical Research and
Materiel Command (USAMRMC) under a recently awarded $500,000 one year extension and amendment of the
previous $1.15 million Phase I and II
SBIR Contract, W81XWH-12-C-0038, and a new $150,000 Phase I SBIR award under Contract No.
W81XWH-16-C-0080. Upon successful completion of the Phase I effort,
the company will be positioned for competitive selection in the
Phase II SBIR program, valued at over one
million dollars. The views, opinion and/or findings
contained in this press release are those of the author(s) and
should not be construed as an official Department of the Army
position, policy or decision unless so designated by other
documentation. In conducting research using animals, the
investigator(s) adhered to the Animal Welfare Act Regulations and
other Federal statutes relating to animals and experiments
involving animals and the principles set forth in the current
version of the Guide of Care and Use of Laboratory Animals,
National Research Council.
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 37 countries around the world, as a safe and
effective 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 such as sepsis, burn injury, trauma, lung
injury and pancreatitis, as well as in cancer immunotherapy. 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, such as
cytokines and free hemoglobin, which can lead to post-operative
complications, including multiple organ failure. CytoSorbents is
currently conducting its REFRESH (REduction in FREe Hemoglobin) 1
trial - a multi-center, randomized controlled study evaluating the
safety of intra-operative CytoSorb® use in a heart-lung machine
during complex cardiac surgery. In early 2017, the company
plans to initiate a pivotal REFRESH 2 trial intended to support
U.S. FDA approval. CytoSorb® has been used safely in more than
12,000 human treatments to date.
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 and contract funding well in excess of $17 million from DARPA, the U.S. Army, the U.S.
Air Force, the U.S. Department of Health and Human Services, the
National Institutes of Health, and others. The Company has numerous
products under development based upon this unique blood
purification technology, protected by 32 issued U.S. patents and
multiple applications pending, including HemoDefend™, ContrastSorb,
DrugSorb and others. For more information, please visit the
Company's
websites: http://www.cytosorbents.com and http://www.cytosorb.com or
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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 9, 2016, 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
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Cytosorbents Contact:
Amy Vogel
Investor Relations
(732) 329-8885 ext. *825
avogel@cytosorbents.com
Public Relations
Contact:
Amy Phillips
Pascale Communications
412-327-9499
amy@pascalecommunications.com
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