MONMOUTH
JUNCTION, N.J., April 14,
2022 /PRNewswire/ -- CytoSorbents
Corporation (NASDAQ: CTSO), a leader in the treatment of
life-threatening conditions in the intensive care unit and cardiac
surgery using blood purification, announces that it has
registered a new subsidiary, CytoSorbents Medical UK Limited,
with plans to establish a direct sales presence within the
United Kingdom (UK) and
Ireland. CytoSorbents previously
sold CytoSorb® via distributor partners within the
region. With a new direct commercialization presence,
CytoSorbents expects to focus its resources and expertise to expand
the use of CytoSorb® in hospitals throughout this
territory, while providing world-class support and education for
physicians and healthcare professionals. The UK is the third
largest medical device market in Europe and the sixth largest in the
world. CytoSorbents will now directly commercialize its
products in 15 countries, with sales in more than 70 countries
worldwide.
CytoSorbents recently hired Mr. Shaun
Whittemore as Country Manager - UK & Ireland, to drive and coordinate market
development in the region. Mr. Whittemore brings 20 years of
sales, marketing and product specialist experience supporting
large, global medical technology companies including LivaNova,
Johnson & Johnson, and Smith+Nephew. Prior to joining
CytoSorbents, Mr. Whittemore was most recently Commercial Manager,
UK & Ireland at LivaNova.
"I am delighted to be part of this exciting opportunity to
further develop and grow the market for CytoSorb in the
United Kingdom and the
Republic of Ireland and expect to
leverage my insight and expertise from a career extending over two
decades within the healthcare sector. I believe the benefits
of our innovative blood purification technology will make a
positive impact on the lives of treated patients throughout the
region," said Whittemore.
Dr. Christian Steiner, Executive
Vice President, Sales and Marketing of CytoSorbents stated, "As we
establish a direct sales team in the UK and Ireland, we are excited to work more closely
with physicians to improve awareness and usage of CytoSorb in its
many applications in critical care and cardiac surgery. We
also expect to continue working with the UK's National Health
Service (NHS), one of the world's largest and well-renowned
healthcare systems, to educate them on the clinical benefits and
cost-effectiveness of our technology. To begin with, we plan
to highlight last year's NICE Medtech innovation briefing on
the use of CytoSorb to reduce the risk of bleeding during
cardiothoracic surgery in patients on blood thinning medications in
the UK health system. Our direct sales expansion into one of
the largest medical device markets in the world is just one of many
new initiatives intended to drive our core growth overall."
About CytoSorbents Corporation
(NASDAQ: CTSO)
CytoSorbents Corporation is a leader in the treatment of
life-threatening conditions in intensive care and cardiac surgery
using blood purification. Its flagship
product, CytoSorb®, is approved in the European
Union with distribution in more than 70 countries around the world
as an extracorporeal cytokine adsorber designed to reduce the
"cytokine storm" or "cytokine release syndrome" seen in common
critical illnesses that may result in massive inflammation, organ
failure and patient death. These are conditions where the
risk of death can be extremely high, yet few to no effective
treatments exist. CytoSorb is also being used during and
after cardiothoracic surgery to remove inflammatory mediators that
can lead to post-operative complications, including multiple organ
failure. More than 162,000 cumulative CytoSorb devices have
been utilized as of December 31,
2021. CytoSorb was originally introduced into the European
Union under CE-Mark as a first-in-kind cytokine adsorber.
Additional CE-Mark label expansions were received for the removal
of bilirubin and myoglobin in clinical conditions such as liver
disease and trauma, respectively, and
both ticagrelor and rivaroxaban during
cardiothoracic surgery. CytoSorb has also received FDA
Emergency Use Authorization in the United States for
use in adult critically ill COVID-19 patients with imminent or
confirmed respiratory failure. The DrugSorb™-ATR
Antithrombotic Removal System, which is based on the same polymer
technology as CytoSorb, has also been
granted FDA Breakthrough Designation for the removal
of ticagrelor, as well as FDA Breakthrough
Designation for the removal of the direct oral anticoagulant
(DOAC) drugs, apixaban and rivaroxaban, in a cardiopulmonary bypass
circuit during urgent cardiothoracic surgery. The Company has
initiated two FDA approved pivotal trials designed to support U.S.
marketing approval of DrugSorb-ATR. The first is the
120-patient, 20 center STAR-T (Safe
and Timely Antithrombotic Removal-Ticagrelor)
randomized, controlled trial evaluating the ability of
intraoperative DrugSorb-ATR use to reduce perioperative bleeding
risk in patients on ticagrelor undergoing cardiothoracic
surgery. The second is the 120-patient, 25
center STAR‑D (Safe
and Timely Antithrombotic Removal-Direct
Oral Anticoagulants) randomized, controlled trial, evaluating the
intraoperative use of DrugSorb–ATR to reduce perioperative bleeding
risk in patients undergoing cardiothoracic surgery on direct oral
anticoagulants, including apixaban and rivaroxaban.
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, contract, and other funding of more
than $39.5 million from DARPA, the U.S. Department of
Health and Human Services (HHS), the National Institutes of Health
(NIH), National Heart, Lung, and Blood Institute (NHLBI), the U.S.
Army, the U.S. Air Force, U.S. Special Operations Command (SOCOM),
Air Force Material Command (USAF/AFMC), and others. The
Company has numerous marketed products and products under
development based upon this unique blood purification technology
protected by many issued U.S. and international patents and
registered trademarks, and multiple patent applications pending,
including ECOS-300CY®, CytoSorb-XL™, HemoDefend-RBC™,
HemoDefend-BGA™, VetResQ®, K+ontrol™,
DrugSorb™, DrugSorb™-ATR, ContrastSorb, and others. For
more information, please visit the Company's websites
at www.cytosorbents.com and 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, future targets and outlooks
for our business, expectations regarding the future impacts of
COVID-19 or the ongoing conflict between Russia and the Ukraine, 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 10, 2022, 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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Investor Relations Contact:
Terri Anne Powers
Vice President, Investor Relations and Corporate Communications
(732) 482-9984
tpowers@cytosorbents.com
U.S. Public Relations Contact:
Eric Kim
Rubenstein Public Relations
212-805-3052
ekim@rubensteinpr.com
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SOURCE CytoSorbents Corporation