MONMOUTH JUNCTION, N.J.,
Dec. 21, 2021 /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 the appointment
of Professor Daniel Wendt, MD, PhD,
MHBA, FETCS as Vice President,
Medical Affairs Cardiovascular commencing January 1, 2022.
Dr. Wendt is an internationally renowned academic cardiac
surgeon with over 15 years of experience in the management of
complex cardiovascular patients and an outstanding academic track
record. Currently, Dr. Wendt serves as Co-director of the Thoracic
and Cardiovascular Surgery Clinic, West German Heart and Vascular
Center in Essen, Germany and is
Professor of Cardiac Surgery at Essen University Medical
School.
During his career, Dr. Wendt performed the full gamut of adult
cardiac surgery procedures, with a special focus on minimally
invasive procedures, including catheter-based structural heart
techniques and served as transcatheter aortic valve implantation
(TAVI) international proctor for Edwards Lifesciences. In
addition, Dr. Wendt has extensive experience in clinical
investigation and has led or participated in multiple large
multicenter studies, including studies supporting CE Mark and FDA
approvals, and an equally impressive academic record with over 150
publications and seats on multiple editorial boards, including the
prestigious Annals of Thoracic Surgery. Importantly, Dr. Wendt
was one of the earliest adopters of CytoSorb® and over the years has
treated hundreds of cardiac surgery patients across multiple
indications, such as acute infective endocarditis, complex aortic
surgery, post-cardiotomy vasoplegia, antithrombotic
removal, and use in combination
with extracorporeal mechanical oxygenation (ECMO). Dr. Wendt
has rigorously captured the outcomes of these patients and to date
has contributed over 10 scientific papers describing the benefits
of CytoSorb use in cardiac surgery.
In his role, Dr. Wendt will be responsible for all
cardiovascular medical affairs activities in support of the CE Mark
approved uses of CytoSorb in cardiac surgery and will also be a key
contributor to the Company's cardiovascular clinical trial
strategy, with the goal of data generation to drive broader
adoption of the therapy across multiple indications.
Dr. Wendt commented, "I am thrilled to join CytoSorbents and
eager to contribute to the Company's leadership position in cardiac
surgery. In my many years in the operating room I have consistently
observed the benefits of cytokine removal with CytoSorb in complex
cardiac operations such as acute endocarditis or complex aortic
surgery and also witnessed the significant reductions in bleeding
when using CytoSorb in urgent operations on patients on
antithrombotic drugs like ticagrelor and rivaroxaban. I am
convinced that CytoSorb could change standard practice and look
forward to working closely with cardiac surgeons around the world
to enhance their understanding of the therapy and drive increased
utilization at their institutions."
Dr. Efthymios Deliargyris, Chief Medical Officer of CytoSorbents
stated, "We are very excited to welcome Dr. Daniel Wendt to CytoSorbents. Daniel's
deep subject matter expertise and extensive international cardiac
surgery network will greatly amplify our efforts in support of
cardiac surgery indications under CE Mark and increase the
visibility of our polymer hemoadsorption technology within the
cardiovascular community worldwide. In addition, his clinical
trial experience will help both the execution of our current
clinical programs and shape the design of future trials. Our
commitment to cardiac surgery has never been greater, evidenced by
our steadfast focus and progress on the FDA approved STAR-T and
STAR-D antithrombotic removal trials, the launch of the
international STAR registry and our continuous investment in top
talent, such as Dr. Wendt, to support our global clinical and
commercialization strategy."
Dr. Wendt received his Medical Degree from the University
Duisburg-Essen Medical School in Essen,
Germany and completed a postdoctoral research fellowship and
his residency at the Thoracic and Cardiovascular Surgery Clinic,
West German Heart and Vascular Center in Essen, Germany. Dr. Wendt has earned the
Habilitation distinction and in 2016 became Full Professor of
Cardiac Surgery (Professor Dr. med. habil) at the Essen University
Medical School. Dr. Wendt is Board-certified by the European
Board of Cardiothoracic Surgery (FETCS) and also obtained his
Master of Health Business Administration (MHBA) from the
Friedrich-Alexander-University School of Business in
Erlangen-Nuremberg, Germany.
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 152,000 cumulative CytoSorb devices have been
utilized to date. 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 is initiating 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,
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, 2021, 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