MONMOUTH JUNCTION, N.J.,
Oct. 5, 2016 /PRNewswire/
-- CytoSorbents Corporation (NASDAQ: CTSO), a therapeutic
device company commercializing its CytoSorb® blood purification
cartridge to control deadly inflammation in critically-ill and
cardiac surgery patients, announced positive top-line safety data
from its recently completed randomized, controlled REFRESH I
cardiac surgery feasibility and safety trial. Following a
detailed review of all reported adverse events in a total of 46
enrolled patients, the independent Data Safety Monitoring Board
(DSMB) found no safety concerns related to the CytoSorb device,
achieving the primary safety endpoint of the trial and fulfilling a
key requisite to move forward with a larger, definitive pivotal
study. In addition, the therapy was well-tolerated and
technically feasible, implementing easily into the cardiopulmonary
bypass circuit without the need for an additional external blood
pump. This study represents the first randomized controlled
trial demonstrating the safety of intra-operative CytoSorb use in
patients undergoing high risk cardiac operations.
The REFRESH (REduction in FREe Hemoglobin)
I trial was a randomized, controlled trial in eight major U.S.
cardiac surgery centers evaluating the safety and feasibility of
CytoSorb® usage intra-operatively during elective, non-emergent
complex cardiac surgery in patients aged 18-80 years of age, where
cardiopulmonary bypass was expected to exceed 3 hours.
CytoSorb cartridges were either installed (treatment) or not
installed (control) in a bypass circuit in the heart-lung machine
during surgery, recirculating blood post-pump and returning it to
the blood reservoir starting 1 hour after beginning cardiopulmonary
bypass (CPB) and continuing to the end of CPB. Inflammatory
biomarkers and clinical parameters were taken hourly during the
surgery and then daily for the duration of the ICU stay. The study
enrolled a total of 46 patients, to achieve evaluable inflammatory
biomarker and clinical data on approximately 40 patients. The
primary safety and efficacy endpoints of the study were the
assessment of serious device related adverse events and the change
in plasma free hemoglobin levels, respectively.
Dr. Robert Bartlett, Chief
Medical Officer of CytoSorbents stated, "We are pleased to have
successfully completed the REFRESH 1 trial, showing that
intra-operative use of CytoSorb in cardiopulmonary bypass is safe,
based upon a review and adjudication of all reported adverse events
by the DSMB. These data support the strong safety profile of
CytoSorb already established in more than 2,500 open heart
surgeries in Europe to date."
Dr. Bartlett continued, "In addition, the data on plasma free
hemoglobin are promising and are pending review by the cardiac
surgery advisory board and trial investigators. Once the
analysis of these data and all relevant data from the trial is
finalized, we plan to discuss our results with the FDA in
anticipation of filing an investigational device exemption (IDE)
application to initiate a pivotal REFRESH 2 trial early next
year. We also plan to submit these data for formal scientific
presentation and future publication."
There are more than 1.5 million open heart surgical operations
performed worldwide each year, with approximately five hundred
thousand in the United States
alone. Approximately 20-25% of all cardiac operations
requiring cardiopulmonary bypass are considered complex, which
includes extensive procedures such as aortic reconstruction,
multiple valve replacement, coronary artery bypass graft (CABG)
re-do operations, left ventricular assist device (LVAD)
implantation, heart transplantation, lung transplantation, and
congenital defect repair. Complex cardiac surgery generates
high levels of plasma free hemoglobin, cytokines, and other
inflammatory mediators that can trigger severe post-operative
inflammation and complications such as organ dysfunction and organ
failure in more than a third of patients. In Europe,
CytoSorb® is being frequently used both during and after cardiac
operations to help prevent or treat these dangerous sequelae.
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 39 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. CytoSorb® has been
used safely in more than 14,000 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 in excess of $18
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 (NIH), National Heart, Lung, and Blood
Institute (NHLBI), U.S. Special Operations Command (SOCOM), 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
CytoSorb-XL, HemoDefend™, ContrastSorb, DrugSorb and others.
For more information, please visit the Company's websites:
http://www.cytosorbents.com and http://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 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
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:
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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SOURCE CytoSorbents Corporation