Aferetica and CytoSorbents Extend Exclusive "Life-saving" Partnership through 2021

MIRANDOLA, Italy and MONMOUTH JUNCTION, N.J., May 22, 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 the renewal of their partnership enabling Aferetica to exclusively distribute CytoSorb in Italy through 2021 for critical care and cardiac surgery applications.  Based on collective expectations, this partnership could result in more than $10 million in sales of CytoSorb to CytoSorbents over the term of the agreement.

CytoSorb is an advanced blood purification technology that has helped many patients survive life-threatening conditions caused by infection, trauma, liver failure, and many other diseases.  It works by reducing a broad range of inflammatory toxins from the blood that could otherwise cause deadly inflammation, organ failure, and fatal outcomes.  Approved in the European Union, CytoSorb has been used safely to help thousands of patients in the areas of critical care, cardiac surgery and organ transplantation.  One of the largest target markets is sepsis – the uncontrolled immune response to a serious infection – which afflicts 30 million people worldwide each year, and causes nearly 10 million deaths. 

Mr. Mauro Atti, CEO of Aferetica stated, "We are proud of our partnership with CytoSorbents that has allowed us to bring CytoSorb^®, and its innovative therapeutic approach, to Italian hospitals where it has already demonstrated its great potential to save human lives.  Since our introduction of CytoSorb^® to the hospital market a little over two years ago, more than 500 patients have been successfully treated in Italy.  We can attest to the many cases in both the intensive care unit and during cardiac surgery where physicians have used CytoSorb^® to stabilize and regain control of their patients in a timely manner, in a wide range of illnesses, including sepsis – the leading killer worldwide.  It has been particularly gratifying to be involved in helping to make a positive difference in the lives of patients and their families.  This includes many victims of the most powerful earthquake to hit central Italy in decades last year."

Mr. Atti continued, "These excellent results, as well as through valuable research activities, have led to strong collaborations with the medical and scientific community in Italy, with increasing usage and more than thirty clinical research projects currently ongoing.  In addition to generating more clinical data, we expect these studies will importantly also demonstrate that CytoSorb reduces the costs of ICU care. The interest in the CytoSorb therapy continues to grow, as seen by our very successful symposium at the 28^th SMART Anesthesia Resuscitation in Intensive Care conference in Milan, where more than 300 people came to learn how to use CytoSorb to treat sepsis, liver failure, and trauma."

"We are also particularly excited about our program in the field of solid organ transplantation, where Aferetica has been working on innovative new projects to maximize the viability of transplanted organs, improve transplant outcomes, and give more potential to human life.  More than 8,000 patients are waiting for donated organs in Italy alone.  CytoSorb can 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.  CytoSorb has a really huge therapeutic potential," Mr. Atti concluded.

Dr. Phillip Chan, CEO of CytoSorbents stated, "Aferetica is an exemplary partner that has used its extensive knowledge, contacts, and experience of blood purification and critical illness to bring CytoSorb to the Italian people.  We have been very impressed by their focus, scientific vision, and leadership, particularly in exciting new growth areas, and welcome the opportunity to work with them on an exclusive basis in Italy for the next 5 years."

Mr. Stefan Baudis, International Sales Director International of CytoSorbents commented, "We congratulate the Aferetica team for their successful work in the past two years with CytoSorb.  Their dedication and passion for the CytoSorb therapy mirrors our own in our direct territories, and we are convinced that this will lead to even greater success in Italy."

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 43 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 23,000 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 in excess of $18 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

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 3, 2017, 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. 

SOURCE CytoSorbents Corporation