MONMOUTH JUNCTION, N.J.,
Dec. 1, 2016 /PRNewswire/
-- CytoSorbents Corporation (NASDAQ: CTSO), a critical care
immunotherapy leader commercializing its European Union approved
CytoSorb® cytokine adsorber to treat deadly inflammation
in critically-ill and cardiac surgery patients worldwide, announced
the publication of a MedTech Innovation Briefing (MIB) on CytoSorb®
for the treatment of sepsis, by the National Institute for Health
and Care Excellence (NICE) in the United
Kingdom (U.K.).
Dr. Phillip Chan, Chief Executive
Officer of CytoSorbents stated, "The selection of CytoSorb by NICE
as an innovative therapy worthy of MIB review is a significant step
towards potential future NICE recommendation for broader clinical
use in the U.K. Only 88 such MIBs have been published since
2014, increasing the prominence of our therapy in the medical
community. With our distribution partner LINC Medical, we
plan to update NICE with new CytoSorb efficacy and
cost-effectiveness data from numerous ongoing studies as they
become available to strengthen our position as one of the most
promising therapies for sepsis today. Our goal is to become
standard therapy for sepsis and other life-threatening conditions
in the U.K – the third largest medical device market in
Europe - and the rest of the
world."
NICE is an independent organization established by the U.K.
government to provide national guidance and advice on medical
treatments to improve healthcare. NICE recommendation is
generally needed for therapies to gain widespread adoption and
reimbursement in the U.K. publicly-funded healthcare system, or
National Health Service (NHS).
MIBs are commissioned by the NHS and produced in support of the
NHS 5-Year Forward View, specifically as one of a number of steps
which will accelerate innovation in new treatments and diagnostics.
According to the MIB frequently asked questions (FAQ) document, new
technologies are selected by the NICE Medical Technologies
Evaluation Programme (MTEP) for MIBs based on:
- Regulatory status, current availability, and degree of
innovation
- The level of NHS interest in the technology
- The relevance to existing, in-development, or future NICE
guidance
- The proposed patient or system benefits
- Whether there is sufficient evidence publicly available to
summarize and critically appraise the technology
The MIB is intended to provide clinicians with an up-to-date
summary of new innovative technologies, how they are used, and what
their potential role is in the treatment pathway. A MIB also
includes a review of relevant published evidence, opinions from
clinical experts in the field, and the likely costs of using the
technology. A MIB is not a treatment guidance document from
NICE and does not constitute a guidance recommendation. MIBs
are updated periodically, and are designed to be fast, flexible,
and responsive to the needs of clinicians for information on
promising technologies.
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 42 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 has
completed its REFRESH (REduction in FREe Hemoglobin) 1 trial - a
multi-center, randomized controlled study that has demonstrated the
safety of intra-operative CytoSorb® use in a heart-lung machine
during complex cardiac surgery. In 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 17,000
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
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Public Relations
Contact:
Amy
Phillips
Pascale Communications
412-327-9499
amy@pascalecommunications.com
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SOURCE CytoSorbents Corporation