CytoSorbents Launches HotSwap™ Technology and Reports Positive Clinical Data for Blood Purification Therapy
核心洞察
CytoSorbents Corporation (搜索) announced the immediate availability of HotSwap (搜索)™, an innovative system designed to enable rapid, seamless exchange of CytoSorb (搜索) adsorbers during treatment of critically-ill patients.
New clinical data from the COSMOS Registry showed significant improvements in vasopressor requirements, oxygenation, and fluid balance (all p<0.0001) with ICU mortality of 32.7% and 90-day survival of 56.5%.
The company renewed its exclusive distribution agreement with Aferetica Srl (搜索) in Italy, extending a successful collaboration spanning more than a decade in critical care and cardiac surgery applications.
CytoSorbents Corporation (搜索) announced three major developments at the International Symposium on Intensive Care and Emergency Medicine (ISICEM) in Brussels, Belgium, including the launch of its HotSwap (搜索)™ technology, renewed partnership agreements, and compelling new clinical evidence supporting its blood purification therapy platform.
HotSwap™ Technology Addresses Critical Care Workflow Challenges
The company announced the immediate availability of HotSwap (搜索)™, an innovative solution designed to enable rapid, seamless exchange of CytoSorb (搜索) adsorbers during treatment of critically-ill patients. The technology addresses key operational challenges in intensive care units by enabling faster, easier device exchanges, particularly in high-acuity patients requiring frequent changes, facilitating safe return of blood from used devices back to patients, and streamlining workflows for ICU staff while reducing nursing burden.
"In critically ill patients, timing, dosing, and treatment intensity are essential to improving outcomes," stated Dr. Phillip Chan, Chief Executive Officer of CytoSorbents. "HotSwap (搜索) enables clinicians to more easily and efficiently treat the right patient, at the right time, with the right dose. Early user feedback has been highly positive, reinforcing our decision to make this technology broadly available."
Dr. Chan explained that in life-threatening diseases such as sepsis (搜索), acute respiratory distress syndrome (搜索), liver failure (搜索), and trauma (搜索), unstable patients often require multiple device changes per day in the early phase of treatment to control deadly massive inflammation or reduce high concentrations of toxic substances that can otherwise lead to organ failure and death. HotSwap (搜索) makes this process faster, safer, and more practical, while preserving valuable blood volume and reducing workload on ICU teams.
Robust Clinical Evidence from Multiple Studies
The company presented substantial new clinical data at ISICEM 2026, with multiple studies demonstrating the therapeutic potential of CytoSorb (搜索) therapy across various critical care applications.
COSMOS Registry Results
The COSMOS Registry, a real-world study involving 306 patients across 23 sites in 6 countries, showed significant clinical improvements. Patients experienced significant reductions in vasopressor requirements, improved oxygenation, and fluid balance (all p<0.0001). The study reported an ICU mortality rate of 32.7%, which was lower than predicted by severity scores, with 90-day survival of 56.5% and greater than 90% dialysis independence.
Rhabdomyolysis Outcomes
A substudy focusing on rhabdomyolysis (搜索) patients (n=45) demonstrated significant reduction in myoglobin (搜索) levels from approximately 8,800 to 3,000 µg/L (p<0.0001), along with improved kidney function markers. The study showed 71% ICU survival with only 8% of patients remaining dialysis-dependent at 90 days.
Toxic Shock Syndrome Case Series
In a case series of seven patients with toxic shock syndrome (搜索), treatment resulted in rapid improvements in SOFA scores, lactate, and inflammatory biomarkers. Shock reversal occurred in 6 of 7 patients, with 6 survivors to ICU discharge.
Comparative Performance Data
An in vitro comparative study demonstrated that CytoSorb (搜索) showed the strongest reduction of inflammatory cytokines (搜索) versus competing hemoperfusion systems, while competing systems showed limited efficacy or unfavorable inflammatory responses.
COVID-19 Meta-Analysis
A meta-analysis in COVID-19 (搜索) patients (n=875) showed a trend toward reduced mortality (OR 0.74) with no evidence of harm, supporting continued use in hyperinflammatory conditions.
Strategic Partnership Renewal
CytoSorbents renewed its exclusive distribution agreement with Aferetica Srl (搜索) in Italy, extending a successful collaboration spanning more than a decade. The partnership has supported widespread adoption of CytoSorb (搜索) across critical care and cardiac surgery in Italy. The companies have also collaborated on Aferetica's innovative PerLife® organ perfusion platform, which integrates CytoSorbents' PerSorb (搜索)® cartridge to improve organ preservation and rehabilitation for transplantation.
"Aferetica has been an exceptional long-term partner," stated Dr. Chan. "CEO Mauro Atti and his team, working closely with leading clinicians and researchers in the country, have played a critical role in advancing both the clinical adoption and scientific understanding of CytoSorb (搜索) therapy."
Mauro Atti, Chief Executive Officer of Aferetica SRL (搜索), stated: "We are happy to continue our successful collaboration with CytoSorbents that has contributed to the growth of our companies and importantly, the care and recovery of many patients. For more than ten years, we have shared the vision that blood purification can significantly improve outcomes in critically ill patients."
Technology Platform and Regulatory Status
CytoSorbents' proprietary blood purification technologies are based on biocompatible, highly porous polymer beads that actively remove toxic substances from blood and other bodily fluids by pore capture and surface adsorption. The company's lead product, CytoSorb (搜索)®, is approved in the European Union and distributed in over 70 countries worldwide, with more than 300,000 devices used cumulatively to date.
CytoSorb (搜索)® was originally launched in the European Union under CE mark as the first cytokine adsorber, with additional CE mark extensions granted for bilirubin and myoglobin (搜索) removal in clinical conditions such as liver disease and trauma (搜索), and for ticagrelor and rivaroxaban removal in cardiothoracic surgery procedures. The device has also received FDA Emergency Use Authorization in the United States for use in adult critically ill COVID-19 (搜索) patients with impending or confirmed respiratory failure, though it is not yet approved or cleared in the United States for broader indications.
"These data and clinical experiences continue to reinforce CytoSorb (搜索)'s role as a versatile, frontline blood purification therapy across a broad range of critical illnesses," added Dr. Chan. "Together with innovations like HotSwap (搜索)™, we are making it easier for clinicians to deliver consistent, high-quality care to the sickest patients."