Gram-negative bacteremia

Goal is to advance new combined blood purification technologies to treat Gram negative sepsis – a deadly global killer PRINCETON, N.J., Oct. 31, 2022 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification via its proprietary polymer adsorption technology, announced today that the National Institute of General Medical Sciences (NIGMS), a division of the U.S. National Institutes of Health, has granted CytoSorbents a Phase I Small Business Innovation Research (SBIR) award valued at $281,835. The eight-month award (Award #1R43GM144973-01) will allow CytoSorbents to test the ability of its novel and existing polymers to remove cytokines and lipopolysaccharide (LPS) endotoxin from septic porcine plasma. LPS endotoxin, released by Gram-negative bacteria such as E. coli, Salmonella, Pseudomonas, Klebsiella, and Legionella, is a well-known potent and deadly trigger of sepsis and septic shock by activating the immune system and generating a cytokine storm that can lead to massive, uncontrolled systemic inflammation, organ failure, and potentially death. Continue Reading Dr. Phillip Chan, MD, PhD, Chief Executive Officer of CytoSorbents stated, "Gram-negative infections play an important and feared role in sepsis, accounting for approximately 40% of cases of septic shock, and more than 30% of hospital-acquired infections. These patients tend to be very sick and have a high risk of death. We are the pioneer in the treatment of sepsis and septic shock by targeting cytokine storm and deadly inflammation with our European Union approved extracorporeal cytokine adsorber, CytoSorb®. But we believe the combination of extracorporeal cytokine and endotoxin removal from blood, in conjunction with antibiotics, may be an even more effective therapy for Gram-negative infections, and will help us to save more lives. We are grateful for the support from NIGMS to conduct the preliminary in vitro work needed before we evaluate our new polymers in a pig model of Gram-negative sepsis in the future." Goal is to advance new combined blood purification technologies to treat Gram negative sepsis - a deadly global killer Tweet this Sepsis is the overzealous immune response to an infection and is responsible for approximately one in every five deaths worldwide each year. This has led the World Health Organization (WHO) to declare it a "global health priority." Sepsis accounts for approximately 10-20% of all intensive care unit (ICU) admissions, where patients either have sepsis when admitted to the ICU, or develop sepsis as a result of a nosocomial or hospital-acquired infection while in the ICU. Gram-negative infections commonly trigger septic shock, a serious complication of sepsis where the blood pressure drops to dangerously low levels and organ failure and death can ensue. Despite antibiotics and the best standard of care, septic shock still has a mortality of 35-50%. The content of this press release is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. About CytoSorbents Corporation (NASDAQ: CTSO) CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in the intensive care unit and in cardiac surgery through blood purification. Its lead product, CytoSorb®, is approved in the European Union and distributed in 75 countries worldwide. It is an extracorporeal cytokine adsorber that reduces "cytokine storm" or "cytokine release syndrome" in common critical illnesses that can lead to massive inflammation, organ failure and patient death. In these diseases, the risk of death can be extremely high, and there are few, if any, effective treatments. CytoSorb is also used during and after cardiothoracic surgery to remove inflammatory mediators that can lead to postoperative complications, including multiple organ failure. As of June 30, 2022, more than 179,000 CytoSorb devices have been used cumulatively. CytoSorb was originally launched in the European Union under CE mark as the first cytokine adsorber. Additional CE mark extensions were granted for bilirubin and myoglobin removal in clinical conditions such as liver disease and trauma, respectively, and for ticagrelor and rivaroxaban removal in cardiothoracic surgery procedures. CytoSorb has also received FDA Emergency Use Authorization in the United States for use in adult critically ill COVID-19 patients with impending or confirmed respiratory failure. The DrugSorb™-ATR antithrombotic removal system, based on the same polymer technology as CytoSorb, also received two FDA Breakthrough Device Designations, one for the removal of ticagrelor and another for the removal of the direct oral anticoagulants (DOAC) apixaban and rivaroxaban in a cardiopulmonary bypass circuit during urgent cardiothoracic procedures. The company has initiated two FDA-approved pivotal studies to support FDA marketing approval of DrugSorb-ATR in the United States. The first is the randomized, controlled STAR-T (Safe and Timely Antithrombotic Removal-Ticagrelor) study of 120 patients at 30 centers to evaluate whether intraoperative use of DrugSorb-ATR can reduce the perioperative risk of bleeding in patients receiving ticagrelor and undergoing cardiothoracic surgery. The second study is the STAR‑D (Safe and Timely Antithrombotic Removal-Direct Oral Anticoagulants) randomized, controlled trial of 120 patients at 30 centers evaluating the intraoperative use of DrugSorb-ATR to reduce perioperative bleeding risk in patients undergoing cardiothoracic surgery and taking direct oral anticoagulants, including apixaban and rivaroxaban. 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 $48 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 and 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, future targets and outlooks for our business, expectations regarding the future impacts of COVID-19 or the ongoing conflict between Russia and the Ukraine, 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 10, 2022, 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. Please Click to Follow Us on Facebook and Twitter Company Contact: Kathleen Bloch (732) 398-5429 [email protected] U.S. Public Relations Contact: Eric Kim Rubenstein Public Relations 212-805-3052 [email protected] SOURCE CytoSorbents Corporation

LITTLE ROCK, Ark., Aug. 29, 2022 /PRNewswire/ -- Scientists at Arkansas Children's Research Institute and Children's Hospital of Philadelphia will use $9.7 million in funding from the National Institutes of Health (NIH) to conduct a first-of-its-kind study to determine if a shorter course of therapy effectively treats uncomplicated candidemia, the most common invasive fungal disease in children. Continue Reading William Steinbach, MD, of Arkansas Children's & University of Arkansas for Medical Sciences Brian Fisher, DO, MSCE, MPH, of Children's Hospital of Philadelphia The seven-year project will help researchers understand whether children with uncomplicated candidemia that has improved after seven days of antifungal therapy can stop treatment at that time or should continue for another seven days which is the current standard of care. This research marks the first randomized, controlled trial to define the optimal duration of therapy for any invasive fungal disease in any age group. While invasive candidiasis can have severe and potentially deadly consequences in immunocompromised patients, much of the invasive candidiasis diagnosed in children is uncomplicated candidemia. Unlike in adults, the vast majority of children with uncomplicated candidemia improve relatively quickly on appropriate antifungal therapy. However, in certain cases, candidemia can result in a more complicated infection that impacts other organs and the musculoskeletal system. Currently, the minimal duration of therapy for candidemia is 14 days regardless of whether it is complicated or uncomplicated. This standard approach can result in unnecessarily long durations of antifungal therapy for uncomplicated candidemia. Researchers will examine the benefits and consequences of the shorter-term treatment of uncomplicated candidemia and assess whether a new molecular biomarker that already allows for rapid diagnoses of children with invasive candidiasis can also indicate the shorter course of therapy may be a better option for patients. "This study will build a foundation for improved guidelines that allow us to treat children more rapidly, reduce the medicine they need and get them back to thriving quickly," said William Steinbach, MD, the study's co-principal investigator, pediatrician in chief at Arkansas Children's and chair of the Department of Pediatrics and associate dean for Child Health at the University of Arkansas for Medical Sciences (UAMS). "The results also will inform future trials in adults and allow us to change guidelines for care of all patients with these diseases." Also leading the study will be Brian Fisher, DO, MSCE, MPH, an attending physician and director of the Pediatric Infectious Diseases Fellowship Training Program at Children's Hospital of Philadelphia. "In addition to being one of the first clinical trials to compare different durations of therapy for invasive fungal disease, this study will also utilize a novel outcome measure referred to as Desirability of Outcome Ranking or 'DOOR,'" Fisher said. "This outcome approach, developed by Dr. Scott Evans at the George Washington University, captures both the benefits and consequences of an intervention which makes it an ideal measure for a trial assessing different durations of antifungal therapy." Randomized clinical trials and studies of bacterial infections such as pneumonia, urinary tract infections and Gram-negative bacteremia have proven that shorter durations of therapy are effective and spare patients some of the unintended consequences of continued anti-infective exposures. The study will leverage the International Pediatric Fungal Network (PFN), a 55-site international research consortium focused on defining the best ways to diagnose and treat deadly invasive fungal infections in children. Drs. Steinbach and Fisher co-lead the network, whose study coordinating center is now housed at Arkansas Children's Research Institute. Its data coordinating center is located at Children's Hospital of Philadelphia. ABOUT ARKANSAS CHILDREN'S Arkansas Children's is the only healthcare system in the state solely dedicated to caring for Arkansas' more than 700,000 children. The private, non-profit organization includes two pediatric hospitals, a pediatric research institute and USDA nutrition center, a philanthropic foundation, a nursery alliance, statewide clinics, and many education and outreach programs — all focused on fulfilling a promise to define and deliver unprecedented child health. Arkansas Children's Hospital is nationally ranked by U.S. News & World Report in seven pediatric specialties (2022—2023): Cancer, Cardiology & Heart Surgery, Diabetes & Endocrinology, Nephrology, Neurology & Neurosurgery, Pulmonology and Urology. Arkansas Children's Research Institute provides an on-site research environment for faculty and scientists of the University of Arkansas for Medical Sciences working on the Arkansas Children's Hospital campus, as they discover life-changing solutions to the most complex children's health problems. To learn more, visit . ABOUT CHILDREN'S HOSPITAL OF PHILADELPHIA A non-profit, charitable organization, Children's Hospital of Philadelphia was founded in 1855 as the nation's first pediatric hospital. Through its long-standing commitment to providing exceptional patient care, training new generations of pediatric healthcare professionals, and pioneering major research initiatives, the 595-bed hospital has fostered many discoveries that have benefited children worldwide. Its pediatric research program is among the largest in the country. The institution has a well-established history of providing advanced pediatric care close to home through its CHOP Care Network, which includes more than 50 primary care practices, specialty care and surgical centers, urgent care centers, and community hospital alliances throughout Pennsylvania and New Jersey, as well as a new inpatient hospital with a dedicated pediatric emergency department in King of Prussia. In addition, its unique family-centered care and public service programs have brought Children's Hospital of Philadelphia recognition as a leading advocate for children and adolescents. For more information, visit . ABOUT UAMS UAMS is the state of Arkansas's only health sciences university, with colleges of Medicine, Nursing, Pharmacy, Health Professions and Public Health; a graduate school; a hospital; a main campus in Little Rock; a Northwest Arkansas regional campus in Fayetteville; a statewide network of regional campuses; and seven institutes: the Winthrop P. Rockefeller Cancer Institute, Jackson T. Stephens Spine & Neurosciences Institute, Harvey & Bernice Jones Eye Institute, Psychiatric Research Institute, Donald W. Reynolds Institute on Aging, Translational Research Institute and Institute for Digital Health & Innovation. UAMS includes UAMS Health, a statewide health system that encompasses all of UAMS' clinical enterprise. UAMS is the only adult Level 1 trauma center in the state. UAMS has 3,047 students, 873 medical residents and fellows, and six dental residents. It is the state's largest public employer with more than 11,000 employees, including 1,200 physicians who provide care to patients at UAMS, its regional campuses, Arkansas Children's, the VA Medical Center and Baptist Health. Visit or . Find us on Facebook, Twitter, YouTube or Instagram. CONTACT Hilary DeMillo [email protected] Wireless phone: 501-416-7981 501-364-6445 Yavonda Chase [email protected] Wireless phone: 501-416-0354 501-686-8994 SOURCE Arkansas Children’s