MONMOUTH JUNCTION, N.J.,
May 27, 2016 /PRNewswire/
-- CytoSorbents Corporation (NASDAQ: CTSO), a critical care
immunotherapy leader commercializing its flagship CytoSorb® blood
purification cartridge to prevent or treat deadly inflammation and
organ failure in critically-ill and cardiac surgery patients around
the world, announced that the independent Data Safety Monitoring
Board (DSMB) of the current U.S. REFRESH I cardiac surgery trial
positively evaluated the safety data from the first 24 patients in
a scheduled meeting, found no safety concerns, and recommended
continuation of the trial to completion without changes.
REFRESH (REduction in FREe Hemoglobin) I is a company-sponsored
40-patient, multi-center, randomized, controlled safety and
feasibility study using CytoSorb® intra-operatively during
elective, non-emergent complex cardiac surgery where
cardiopulmonary bypass is expected to last longer than 3 hours. The
primary endpoints are safety of treatment and efficacy of plasma
free hemoglobin removal from blood. The study is being performed by
eight major U.S. cardiac surgery centers under the guidance of the
Company's cardiac surgery advisory board. With a successful
conclusion of REFRESH I and a meeting with the U.S. Food and Drug
Administration (FDA), the company plans to submit an
investigational device exemption (IDE) application later this year
to initiate a pivotal, registration REFRESH 2 trial.
Dr. Robert Bartlett, Chief
Medical Officer of CytoSorbents, stated, "We are pleased that the
DSMB has recommended continuation of the REFRESH I trial without
modifications. Their conclusion mirrors the general
experience in more than 1,500 cardiac surgeries in Europe to date, where CytoSorb® has been used
safely intra-operatively, with the goals of controlling
inflammation, stabilizing patients, and reducing the risk of
serious post-operative complications such as shock, acute kidney
injury, and lung failure. With more than two-thirds of the
patients enrolled, we remain focused on enrolling this important
study to completion in the next several
months."
There are more than 1.5 million open heart surgery procedures
performed worldwide each year, with approximately 500 thousand in
the United States alone.
Approximately 20-25% of all cardiac surgeries 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 peri-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 surgery to help
prevent or treat these dangerous sequelae.
About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorb® is approved in the European Union with distribution in
32 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 12,000
human treatments to date, of which more than 1,500 devices have
been used during open heart 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. 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. Additional information is available for
download on the Company's websites:
http://www.cytosorbents.com and http://www.cytosorb.com
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.
Please Click to Follow Us on Facebook and
Twitter
Cytosorbents Contact:
Amy Vogel
Investor
Relations
(732) 329-8885 ext. *825
avogel@cytosorbents.com
Investor Contact:
Lee Roth
The Ruth
Group
646-536-7012
lroth@theruthgroup.com
Public Relations
Contact:
Christopher
Hippolyte
The Ruth
Group
646-536-7023
chippolyte@theruthgroup.com
Logo -
http://photos.prnewswire.com/prnh/20140408/MM00899LOGO
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/independent-data-safety-monitoring-board-recommends-continuation-of-cytosorbents-refresh-i-trial-300276070.html
SOURCE CytoSorbents Corporation