MONMOUTH JUNCTION, N.J. and
BOLOGNA, Italy, Aug. 30, 2021 /PRNewswire/ -- CytoSorbents
Corporation (NASDAQ: CTSO) and Aferetica srl (Italy), two pioneers in intensive care
immunotherapy and blood purification, announce the commercial
launch of Aferetica's PerLife™ ex vivo organ perfusion
system for kidney and liver transplant and CytoSorbents' PerSorb™
adsorber, based on the CytoSorbents ECOS-300CY™ sorbent technology
to remove inflammatory mediators during ex vivo organ
perfusion, at the European Society of Organ Transplantation (ESOT)
Congress in Milan, Italy from
August 29 – September 1, 2021.
CytoSorbents and Aferetica Announce the Commercial Launch of the
PerSorb™ Adsorber and PerLife™ Organ Perfusion System
The PerLife and PerSorb technologies will be showcased in
Aferetica's Booth #26 in the main exhibit hall and highlighted at
the company-sponsored symposium "From Organ Preservation to
Organ Regeneration" on Tuesday, August
31, 2021 from 1:15-2:15PM CEST
in Turquoise Room 1.
Chairs:
- L. De Carlis (University of Milan
Bicocca, Italy) and F. D'Ovidio
(Columbia University, USA)
Speakers:
- G. Remuzzi (Mario Negri Institute, Italy)
Expanding the Organ
Transplant Pool: The Role of Ex Vivo Perfusion
- S. Hosgood (University of
Cambridge, U.K.)
The Inflammatory Mediators and
Graft Function: The Kidneys
- M. Boffini & M. Rinaldi (University of Turin, Italy)
Cytokines,
Transplantability, Primary Graft Dysfunction, Survival: The
Lungs
- F. Dazzi (King's College, U.K.)
Mesenchymal
Stromal Cells: Should they be Integrated in Machine Perfusion
Devices?
Dr. Mauro Atti, Chief Executive
Officer of Aferetica stated, "Today is a significant step forward
for the PerLife project with the commercial launch at the ESOT
Congress, which sets the stage for the international launch of the
combined PerLife and PerSorb system. We believe we can
revolutionize the world of transplantation with the first system
capable of supporting both hypothermic and normothermic organ
support in one machine. We have reached this milestone thanks
to many academic collaborations with leading national and
international experts and our partnership with
CytoSorbents. We take great pride and satisfaction in this
accomplishment."
Dr. Atti continued, "At tomorrow's symposia, key opinion leaders
will present studies with results showing the importance of ex
vivo perfusion in the preservation and recovery of organs
intended for transplantation. The PerLife™ platform for the ex
vivo perfusion of livers and kidneys, integrated with the
PerSorb™ sorbent that was developed in collaboration with
CytoSorbents allows the removal of inflammatory mediators that can
cause short- and long-term damage to organs. In doing so, the
combined technologies provide a unique system to support and
minimize damage to donated organs prior to transplant."
Dr. Christian Steiner, Executive
Vice President of Sales and Marketing of CytoSorbents stated, "We
are excited to work with Aferetica to launch our combined solution
for ex vivo perfusion of kidneys and livers. Demand for
donated organs continues to increase in Europe, as well as around the world, which has
been exacerbated by a decrease in donated organs due to the
COVID-19 pandemic. In Europe,
kidneys are the most transplanted organs, at 63% of all solid organ
transplants, while liver transplants are the second highest at
23%. We believe utilization of the PerLife and PerSorb
combined solution can improve the quality and viability of donated
kidneys and livers, a life-saving innovation that can make a
tremendous difference in the lives of patients requiring organ
transplant."
PerLife is a revolutionary, integrated, therapeutic system for
organ transplant that is the first to provide both perfusion and
purification of the kidney and the liver, following organ retrieval
and before organ implantation. The platform integrates innovative
patented technologies creating an all-in-one machine capable of
covering the broad range of temperature preservation techniques
(hypothermic and normothermic) while incorporating CytoSorbents'
PerSorb perfusion cartridge to remove inflammatory mediators that
can compromise the health and quality of the organs. The main
goal of combining these two European Union approved therapies is to
increase successful solid organ transplants by helping to preserve
good organs, rehabilitate sub-optimally functioning ones, and to
increase the overall pool of viable organs to meet the growing
worldwide demand for transplanted organs. Today, this need is
being driven by record rates of kidney and liver failure caused by
globally pervasive health crises such as the aging population,
diabetes, hypertension, obesity, alcoholism, hepatitis, and
non-alcoholic steatohepatitis (NASH), also called "fatty
liver."
Viable organs for transplant are scarce, yet the number of
patients awaiting transplant continues to grow globally, with more
than 150,000 candidates waiting for transplants in Europe alone. In 2019, 41,000 patients
received solid organ transplants in the E.U., while 48,000 new
patients were added to the transplant list and approximately 4% (or
6,000) died awaiting a transplant. As demand for donor organs
continues to outpace availability and as patients run out of
options, transplant centers are now supplementing viable organs
with marginal ones. However, some studies suggest organs from
this expanded donor pool have a higher risk of primary graft
failure and organ rejection compared to "ideal
donors." Inflammatory mediators and cytokines, such as IL-6,
appear to play a role in this progressive loss of function, and
have been correlated with an increased risk of death in
recipients. By providing perfusion and purification following
kidney or liver donation and before transplant, the PerLife
platform and PerSorb cartridge have the potential to significantly
change how these organs are treated before transplant, and to
increase successful transplant outcomes.
About Aferetica srl
Aferetica was founded in January
2014 as an innovative start-up registered in the national
register (Law 221/2012), within the incubator of the Mirandola
Science and Technology Park. As of 2019, Aferetica became an
innovative Small and Medium Enterprise. The business focus
covers a broad range of extracorporeal interventions under the
broad umbrella of therapeutic apheresis. In addition to
transplantation, Aferetica has driven innovation based on
extracorporeal therapies in a variety of clinical areas, such as:
Neurology, Autoimmune Diseases, Diabetes, Rheumatology, Nephrology
and Intensive Care. Aferetica's know-how in Medical Device
development comes from decades of experience from the founders of
Aferetica, Mauro Atti (former
scientific director of Belco) and Stefano
Rimondi, past president of Assobiomedica). For more
information: http://www.aferetica.com.
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 68 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 143,000 CytoSorb devices have been
delivered 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, rivaroxaban and
apixaban, in a cardiopulmonary bypass circuit during urgent
cardiothoracic surgery.
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, anticipated future results
and performance, 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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CytoSorbents Investor Relations Contact:
Terri Anne Powers
Vice President, Investor Relations
and Corporate Communications
(732) 482-9984
tpowers@cytosorbents.com
CytoSorbents U.S. Public Relations Contact:
Eric Kim
Rubenstein Public Relations
212-805-3052
ekim@rubensteinpr.com
Aferetica Press Office:
paola.abruzzese@mec-partners.it
roberta.sforza@mec-partners.net
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