CytoSorbents Enrolls First Patient in TISORB Trial and Opens Operating Subsidiary in the United Kingdom

MONMOUTH JUNCTION, N.J., Nov. 1, 2019 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in blood purification therapies to treat life-threatening conditions, announced the first patient enrollment in the company-sponsored Ticagrelor CytoSorb® Hemoadsorption (TISORB) study in the United Kingdom (U.K.).  The Company also announced establishment of a new U.K. operating subsidiary, CytoSorbents UK Limited, that enables it, among other things, to be eligible for certain research tax credits that are expected to subsidize the trial by up to a third of the cost, subject to certain restrictions.

CytoSorbents Logo. (PRNewsFoto/CytoSorbents)

The U.K. TISORB study is a 30-patient, open-label, prospective, multi-center, single arm clinical trial designed to evaluate the ability of CytoSorb®, when used in patients undergoing emergency open heart surgery within 48 hours of their last dose of ticagrelor, to remove ticagrelor and reverse the inhibitory effect of the drug on platelet aggregation. The trial is expected to complete by August 2020. Platelets are small cell fragments that are necessary to form blood clots, and without functioning platelets that can aggregate or stick together, surgical patients are at high risk of bleeding during and after surgery.  Ticagrelor (Brilinta®, Astra Zeneca) is a widely-used anti-platelet agent used to decrease cardiovascular risk and risk of stroke in patients with a known history of heart disease or heart attack.  However, when patients on ticagrelor suffer from a cardiac event that requires emergency cardiac surgery, approximately 25-30% will have severe or massive peri-operative bleeding complications that contributes to a high risk of death and major costs to the healthcare system.  CytoSorb has already demonstrated the ability to remove ticagrelor rapidly and efficiently from human blood in vitro.  Meanwhile, a retrospective case series reported by clinicians at Asklepios Klinik St. Georg in Hamburg, Germany on the investigational use of CytoSorb to reverse the effects of ticagrelor during emergency cardiac surgery demonstrated a greatly reduced risk of bleeding complications and the need for repeat surgery to explore the source of bleeding, with extrapolations showing projected cost savings of £3,982, or approximately $5,000 USD, per patient in a U.K. based study. 

Dr. Nawwar Al-Attar, Consultant Cardiac & Transplant Surgeon at the Golden Jubilee National Hospital in Glasgow, Scotland, an investigator in the TISORB study, commented,  "We are excited to participate in this prospective study to further evaluate the effectiveness of the CytoSorb adsorber to remove ticagrelor and restore platelet function in patients on the drug who require emergency cardiac surgery.  This is a large unmet need for these patients who have an increased risk of suffering from catastrophic bleeding and its resultant complications.  Treatment with CytoSorb has the potential to significantly improve the outcomes for these patients as well as to reduce the costs associated with these bleeding complications." 

Dr. Kenichi Tanaka, Professor and Head of Cardiothoracic Anesthesiology at the University of Maryland School of Medicine added, "Anti-thrombotic drugs such as ticagrelor are important for patients to prevent heart attacks and strokes.  However, for patients who require emergency cardiothoracic surgery, being on these drugs greatly increases the risk of serious bleeding.  Some life-saving surgeries need to be done immediately instead of waiting for a few days until the drug wears off.  Having the ability to remove anti-thrombotic drugs prior to, or during emergency cardiothoracic surgery, has the potential to allow these procedures to be performed safely in critically-ill patients by reducing bleeding and possible complications related to allogeneic blood transfusions.  The initiation of the TISORB study is an important first step toward filling an unmet need in perioperative management of ticagrelor."

Dr. Eric Mortensen, MD, PhD, Chief Medical Officer of CytoSorbents, commented, "The initiation of the TISORB study is an important milestone for our company. This study, and a planned companion study, are expected to provide confirmatory mechanistic, clinical, and cost-effectiveness data, that if successful, may support broader use of CytoSorb in the United Kingdom and elsewhere.  This is the first time that CytoSorbents has sponsored a clinical trial in the U.K. and we look forward to collaborating with our investigator colleagues."

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 58 countries around the world, as an 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. 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 reduce inflammatory mediators that can lead to post-operative complications, including multiple organ failure. CytoSorbents is conducting its pivotal REFRESH 2-AKI trial – a multi-center, randomized controlled, clinical trial intended to support U.S. regulatory approval of CytoSorb for use in a heart-lung machine during complex cardiac surgery to reduce organ injury.  The Company has also initiated the company-sponsored U.K. TICAG trial evaluating the removal of ticagrelor in emergency cardiac surgery patients.  CytoSorb® has been used in more than 67,000 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 $29 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 many issued U.S. and international patents and multiple applications pending, including CytoSorb-XL™, HemoDefend™, VetResQ™, K+ontrol™, 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 7, 2019, 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 Contact:
Amy Vogel
Investor Relations
(732) 398-5394
avogel@cytosorbents.com

Investor Relations Contact:
Jeremy Feffer
LifeSci Advisors
917-749-1494
jeremy@lifesciadvisors.com

Public Relations Contact:
Joshua Berkman
Rubenstein Public Relations
212-805-3055
jberkman@rubensteinpr.com

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SOURCE CytoSorbents Corporation

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