MIRANDOLA, Italy and MONMOUTH JUNCTION, N.J., Sept. 11, 2017 /PRNewswire/ -- Aferetica srl, an innovative start-up specializing in blood purification, and CytoSorbents Corporation (NASDAQ: CTSO), a critical care immunotherapy
leader commercializing CytoSorb® to treat deadly inflammation, announced a new collaboration to jointly
develop the PerLife™ ex-vivo organ perfusion system with CytoSorbents' novel adsorption technologies that can cleanse and
recondition harvested solid organs such as the kidney, lungs, heart, and liver prior to transplantation. The goal of the therapy
is to improve the functioning and viability of the organs, while reducing the risk of primary graft failure and organ rejection.
This may help to recondition marginal organs that are typically discarded, expand the availability of scarce, suitable organs,
and ensure the success of costly transplantation procedures.
Under the terms of the agreement, Aferetica will lead the development and regulatory approval of the PerLife System, while
CytoSorbents will provide dedicated, branded sorbent cartridges for use with the platform. CytoSorbents and Aferetica will
finalize the commercial arrangements for distributing the PerLife System, including sorbent cartridges, prior to the anticipated
market introduction starting in Italy later this year and followed by select European Union
countries in 2018.
Mr. Mauro Atti, Chief Executive Officer of Aferetica stated, "We are delighted to expand our
relationship with CytoSorbents, where we have successfully introduced CytoSorb to Italian hospitals where it has demonstrated its
great potential to save lives. Together, we will now target the rapidly growing field of organ transplantation.
Aferetica has been advancing the PerLife System to maximize the viability of transplanted organs, improve transplant
outcomes, and give more potential to human life. The PerLife System, when combined with CytoSorbents' novel purification
technology, has the potential to play an important role before, during, and after transplant surgery, as already confirmed by
recent and important studies in collaboration with some of the most important Italian universities."
Dr. Phillip Chan, Chief Executive Officer of CytoSorbents stated, "Currently, there is a severe
worldwide shortage of donor organs. According to the Global Observatory on Donation & Transplantation, there were approximately 120,000 solid organs transplanted
in 2014, which was less than 10% of the global need. Transplanted kidneys account for approximately two-thirds of all
transplants, yet based on research performed by UNOS, the United Network for Organ Sharing, nearly 20 percent of all deceased
donor kidneys are discarded, mainly because they do not meet kidney donor quality criteria. For example, cytokine storm and
severe inflammation in organ donors who die of traumatic injury can damage and reduce the functioning of these organs, resulting
in a higher risk of graft failure after transplant, and even decreased long-term survival. By reconditioning organs prior
to transplant, the PerLife System, utilizing CytoSorbents' sorbent technology, has the potential to positively impact the field,
by improving the quality and supply of harvested organs, while reclaiming many marginal organs that would otherwise be
discarded."
Mr. Chris Cramer, Vice President of Business Development of CytoSorbents commented, "The
expansion of this partnership is very exciting because it provides the opportunity to bring CytoSorbents' sorbent technology to a
new set of customers in a new clinical application where there is a major unmet medical need. We believe the use of the
PerLife system to optimize organ function before the surgery, and CytoSorb after the surgery, if needed, will enable transplant
surgeons to experience the benefits of CytoSorbents' technologies. Aferetica has been an outstanding partner and has already
demonstrated the ability to rapidly grow the CytoSorb business in Italy. We are pleased to
launch this collaboration for organ transplantation with Aferetica and look forward to continued success with them in this new
field."
About Aferetica srl (Mirandola, Modena)
Founded by Mauro Atti and Stefano Rimondi, leaders with decades
of experience in dialysis, intensive care, cardiology and medical devices in general, Aferetica is innovative
start-up specializing in blood purification to provide the Health care system with systems for therapeutic
apheresis to support special procedures like Organ Transplant and to treat critical illnesses such as sepsis, autoimmune
diseases, and other illnesses caused by undesirable mediators.
Aferetica is based in the incubator of the Biomedical District of Mirandola, Italy, district
that brings with it as a common heritage of knowledge, technologies, and production capacities allowing to quickly and
efficiently develop therapies and products. Most of the innovations born in Europe in the field
of blood purification spring from ideas and activities carried out in collaboration between industry, clinicians, and
academicians around this territory. The Aferetica partners have always believed this is the main road leading to real and
concrete innovation and have with their activities contributed to the growth of collaborative research, the building block of the
company.
For more information, please visit the company website: http://www.aferetica.com
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
44 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 and efficacy of free hemoglobin reduction with
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
27,000 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, contract, and other funding of approximately $20 million from DARPA, the U.S. Army, 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™, VetResQ™, ContrastSorb, DrugSorb, 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
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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 3, 2017, as updated by the risks reported in our Quarterly Reports on Form 10-Q, and in the press
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SOURCE CytoSorbents Corporation