MONMOUTH JUNCTION, N.J.,
Dec. 7, 2016 /PRNewswire/
-- CytoSorbents Corporation (NASDAQ: CTSO), a critical care
immunotherapy leader commercializing its CytoSorb® blood
purification therapy to treat deadly inflammation in
critically-ill and cardiac surgery patients across 42 countries,
announces the achievement of a permanent, dedicated reimbursement
procedure code for the CytoSorb® therapy in Germany, providing for specific and enhanced
reimbursement in the largest medical device market in Europe.
Dr. Christian Steiner, Vice
President of Sales and Marketing for CytoSorbents stated, "We have
worked diligently for the past several years to attain this key
foundational milestone that is expected to catalyze major increases
in adoption and sales of CytoSorb in Germany. The relatively short time frame in
which this specific reimbursement code was granted is remarkable,
and validates the importance and value of our CytoSorb therapy to
physicians in Germany, where its
usage has seen tremendous growth. Of note, this new
reimbursement was achieved with the strong and broad support from
several major German medical societies, across different medical
specialties."
Dr. Steiner continued, "Our previous reimbursement was more
generic, and led in many cases to inadequate reimbursement,
impeding usage and sales. Now, with several years of CytoSorb
treatment cost data and a dedicated reimbursement code specific to
our therapy, we believe our customers will be able to negotiate
significantly higher reimbursement under the new code that covers
not only the cost of the device, but the procedural costs as
well. The new code has now been communicated throughout the
entire CytoSorb hospital customer base in the country and becomes
effective January 1, 2017.
Furthermore, we expect that this enhanced reimbursement in the
leading country in the European Union will have a positive impact
on reimbursement in other countries as well."
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
and 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