MONMOUTH JUNCTION, N.J.,
Feb. 2, 2015 /PRNewswire/
-- CytoSorbents Corporation (NASDAQ CM: CTSO), a critical care
immunotherapy company commercializing its CytoSorb® extracorporeal
cytokine adsorber to treat critically-ill and cardiac surgery
patients in multiple countries worldwide, announced that the U.S.
Food and Drug Administration (FDA) has approved its Investigational
Device Exemption (IDE) application to commence a planned U.S.
cardiac surgery feasibility study. This single-arm study in
20 patients and three U.S. clinical sites represents the first part
of a larger clinical trial strategy intended to support the U.S.
approval of CytoSorb® for intra-operative use during cardiac
surgery.
The study is designed to evaluate the safety of CytoSorb® when
used intra-operatively in a heart-lung machine to reduce plasma
free hemoglobin and cytokines in patients undergoing complex
cardiac surgery. The length, complexity and invasiveness of
these procedures cause hemolysis and inflammation, leading to high
levels of plasma free hemoglobin, cytokines, activated complement,
and other substances. These inflammatory mediators directly
correlate with the incidence of serious post-operative
complications such as kidney injury and failure. The goal of
CytoSorb® is to actively remove these inflammatory and toxic
substances as they are being generated during the surgery and
reduce complications.
Concurrently, the Company is funding a non-interventional study
amongst a broader array of U.S. cardiac surgery centers that will
assess adverse event rates (e.g. incidence of acute kidney injury
and respiratory failure) and levels of free hemoglobin and other
inflammatory mediators in patients undergoing complex cardiac
surgery. These patients will be selected using similar
inclusion and exclusion criteria to the feasibility study.
The data from these two studies will help to rapidly validate
assumptions in this surgical patient population and help to
appropriately power a U.S. pivotal cardiac surgery trial.
Dr. Gregory Di Russo, Senior Vice
President of Clinical Development at CytoSorbents stated, "Pending
institutional review board (IRB) approval at our selected sites, we
look to rapidly execute the feasibility study and advance the
non-interventional study. We plan to work with these same
institutions to begin a pivotal trial in the future with critical
mass. Positive data from a U.S. pivotal trial and from
cardiac surgery trials ongoing in Europe may help to establish CytoSorb® as a
standard component of the heart-lung machine during cardiac surgery
and fill a significant unmet medical need."
Mr. Vincent Capponi, Chief
Operating Officer of CytoSorbents stated, "We are excited to begin
these trials, as they underscore our commitment to seeking U.S.
approval of CytoSorb® for cardiac surgery. With strong
interest from leading international cardiac surgery companies, and
with success in our clinical trial programs, we believe that future
approval in the U.S. will help pave the way for multiple
commercialization options of CytoSorb® in the US and abroad. "
There are more than 500,000 cardiac surgeries performed in
the United States, and more than
1.5 million surgeries worldwide each year for common applications
such as coronary artery bypass graft (CABG) surgery, valve repair
or replacement, congenital defect repair, heart/lung
transplantation, implantation of left ventricular assist devices
(LVAD) for heart failure, and others. This represents
an estimated total addressable market of more than $1.5 billion for CytoSorb® in this indication
alone, and adds to the overall $20
billion market potential of CytoSorb® for critical care
applications worldwide.
About CytoSorbents Corporation
CytoSorbents Corporation is a critical care focused
immunotherapy company using blood purification to control severe
inflammation -- with the goal of preventing or treating multiple
organ failure in life-threatening illnesses. Organ failure is the
cause of nearly half of all deaths in the intensive care unit, with
little to improve clinical outcome. CytoSorb®, the Company's
flagship product, is approved in the European Union and marketed in
29 countries around the world, as a safe and effective
extracorporeal cytokine adsorber, designed to reduce the "cytokine
storm" that could otherwise cause massive inflammation, organ
failure and death in common critical illnesses such as sepsis, burn
injury, trauma, lung injury, and pancreatitis. 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' 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. CytoSorbents has numerous products
under development based upon this unique blood purification
technology, protected by 32 issued US patents and multiple
applications pending, including HemoDefend™, ContrastSorb,
DrugSorb, and others. Additional information is available for
download on the Company's website:
http://www.cytosorbents.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 31, 2014, 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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SOURCE CytoSorbents Corporation