Full Press Release Details
CytoSorbents and Aferetica Announce the Commercial
Launch in Italy of the PerSorb Adsorber and PerLife Organ Perfusion System, respectively, at the European Society of Organ
Transplantation Congress
MONMOUTH JUNCTION, N.J.,
and BOLOGNA, ITALY, August 30, 2021 - 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.
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.
the Organ Transplant Pool: The Role of Ex Vivo Perfusion
Mediators and Graft Function: The Kidneys
Transplantability, Primary Graft Dysfunction, Survival: The Lungs
Stromal Cells: Should they be Integrated in Machine Perfusion Devices?
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
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)
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
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
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