CytoSorbents Announces HotSwap™ Launch, Renewed Aferetica Partnership, and New Clinical Evidence at ISICEM 2026
Rhea-AI Summary
CytoSorbents (NASDAQ: CTSO) announced three developments at ISICEM 2026: the immediate launch of HotSwap™ to enable faster adsorber exchanges, renewal of its exclusive Italian distribution with Aferetica, and new clinical data (COSMOS registry n=306 and multiple studies) strengthening CytoSorb® evidence.
Key clinical highlights include reductions in vasopressor needs, improved oxygenation, myoglobin declines in rhabdomyolysis, and a COVID-19 meta-analysis showing a mortality trend.
Positive
- HotSwap™ immediate commercial availability
- COSMOS registry: n=306 multi‑country real‑world data
- COSMOS: vasopressor and oxygenation improvements (p<0.0001)
- Rhabdomyolysis substudy: myoglobin reduced ~8,800→~3,000 µg/L
- Renewed exclusive Italy distribution with Aferetica (>10 years)
Negative
- Toxic Shock case series: very small sample (n=7)
- Rhabdomyolysis substudy limited size (n=45)
- COVID-19 meta-analysis shows trend, not definitive mortality benefit (OR 0.74)
News Market Reaction – CTSO
In the Mar 19 session, CTSO declined 1.86%, reflecting a mild negative market reaction. Argus tracked a trough of -14.3% from its starting point during tracking. Our momentum scanner triggered 4 alerts that day, indicating moderate trading interest and price volatility. Trading volume was elevated at 2.1x the daily average, suggesting increased selling activity.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Previous Partnership Reports
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Nov 11 | India distribution partnership | Positive | +25.7% | Strategic partnership to expand CytoSorb critical care reach in India. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Past partnership news has coincided with a strong positive price reaction.
In November 2024, CytoSorbents announced a strategic partnership with Converge Biotech to expand CytoSorb use in India, targeting sepsis and broader critical care. That partnership news saw a 25.68% positive move the next day. Today’s ISICEM 2026 update combines a renewed Aferetica partnership in Italy with the HotSwap™ launch and new clinical data, extending the theme of international collaboration and adoption in critical care and organ transplantation.
Key Terms
hemoadsorption medical
cytokine release syndrome medical
car-t cell therapy medical
sofa scores medical
meta-analysis medical
odds ratio medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
- The introduction of HotSwap™ by CytoSorbents – The New CytoSorb exchange system
- The renewal of its long-standing partnership with Aferetica Srl in
Italy , and - New clinical data reinforcing the growing body of evidence supporting CytoSorb® therapy
CytoSorbents Launches HotSwap™ to Simplify and Optimize Therapy
CytoSorbents announced the immediate availability of HotSwap™, an innovative solution designed to enable rapid, seamless exchange of CytoSorb adsorbers during the treatment of critically-ill patients. HotSwap™ is designed to:
- Enable faster, easier device exchanges – particularly in high-acuity patients requiring frequent changes
- Facilitate the safe return of blood from used devices back to the patient
- Streamline workflows for ICU staff, reducing nursing burden and improving treatment consistency
"In critically ill patients, timing, dosing, and treatment intensity are essential to improving outcomes," stated Dr. Phillip Chan, Chief Executive Officer of CytoSorbents. "HotSwap 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 added, "In life-threatening diseases such as sepsis, acute respiratory distress syndrome, liver failure, and trauma, unstable patients often require multiple device changes per day in the early phase of treatment to control deadly massive inflammation or to reduce high concentrations of toxic substances that can otherwise lead to organ failure and death. HotSwap makes this process faster, safer, and more practical, while preserving valuable blood volume and reducing the workload on ICU teams."
CytoSorbents Renews Strategic Partnership with Aferetica
CytoSorbents also announced the renewal of its exclusive distribution agreement with Aferetica Srl in
"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 therapy. We are excited to continue working together to expand innovation in blood purification and organ transplantation."
Mr. Mauro Atti, Chief Executive Officer of Aferetica SRL 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. Together we have successfully expanded from sepsis into liver failure and other critical illnesses, and now organ transplantation. We look forward to many more years of continued progress and shared success."
New Clinical Data and Scientific Leadership at ISICEM 2026
Today, CytoSorbents is hosting a featured symposium at ISICEM entitled:
"Hemoadsorption as part of an individualized patient concept in Intensive Care – Key Learnings and Best Practices"
Chair: Dr. Ricard Ferrer,
- The importance of timing and dosing in different indications
Dr. Gerd Klinkmann, Rostock/Germany
- Update on drug removal – we are on the safe side if we do it right
Dr. Gabriella Bottari,Rome/Italy
- The new kid on the block – Cytokine Release Syndrome (CRS) after CAR-T cell therapy
Dr. Peter Pickkers, Nijmegen/The Netherlands
In addition, multiple abstracts and poster presentations presented at ISICEM further strengthen the clinical evidence base for CytoSorb therapy (click on title for full abstract):
COSMOS Registry – Real-World Critical Care Outcomes (n=306, 23 sites, 6 countries)
- Significant reductions in vasopressor requirements, improved oxygenation, and fluid balance (all p<0.0001)
- ICU mortality of
32.7% , lower than predicted by severity scores - 90-day survival of
56.5% , with >90% dialysis independence
Rhabdomyolysis Substudy (n=45)
- Significant reduction in myoglobin levels (~8,800 → ~3,000 µg/L, p<0.0001)
- Improved kidney function markers
71% ICU survival; only8% dialysis-dependent at 90 days
Toxic Shock Syndrome Case Series (n=7)
- Rapid improvements in SOFA scores, lactate, and inflammatory biomarkers
- Shock reversal in 6 of 7 patients; 6 survivors to ICU discharge
- CytoSorb demonstrated the strongest reduction of inflammatory cytokines versus competing hemoperfusion systems
- Competing systems showed limited efficacy or unfavorable inflammatory responses
Meta-Analysis in COVID-19 (n=875)
- Trend toward reduced mortality (OR 0.74)
- No evidence of harm, supporting continued use in hyperinflammatory conditions
"These data and clinical experiences continue to reinforce CytoSorb's role as a versatile, frontline blood purification therapy across a broad range of critical illnesses," added Dr. Chan. "Together with innovations like HotSwap™, we are making it easier for clinicians to deliver consistent, high-quality care to the sickest patients."
About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery through blood purification. CytoSorbents' proprietary blood 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. Cartridges filled with these beads can be used with standard blood pumps already in the hospital (e.g. dialysis, continuous renal replacement therapy or CRRT, extracorporeal membrane oxygenation or ECMO, and heart-lung machines), where blood is repeatedly recirculated outside the body, through our cartridges where toxic substances are removed, and then back into the body. CytoSorbents' technologies are used in a number of broad applications. Specifically, two important applications are 1) the removal of blood thinners during and after cardiothoracic surgery to reduce the risk of severe bleeding, and 2) the removal of inflammatory agents and toxins in common critical illnesses that can lead to massive inflammation, organ failure and patient death. The breadth of these critical illnesses includes, for example, sepsis, burn injury, trauma, lung injury, liver failure, cytokine storm and cytokine release syndrome, and pancreatitis as well as the removal of liver toxins that accumulate in acute liver dysfunction or failure, and the removal of myoglobin in severe rhabdomyolysis that can otherwise lead to renal failure. In these diseases, the risk of death can be extremely high, and there are few, if any, effective treatments.
CytoSorbents' lead product, CytoSorb®, is approved in the European Union and distributed in over 70 countries worldwide, with more than 300,000 devices used cumulatively to date. 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. CytoSorb® is not yet approved or cleared in the United States.
In the U.S. and Canada, CytoSorbents is developing the DrugSorb®-ATR antithrombotic removal system, an investigational device based on an equivalent polymer technology to CytoSorb®, to reduce the severity of perioperative bleeding in high-risk surgery due to blood thinning drugs. It has 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 surgery. The Company is actively pursuing regulatory approval of DrugSorb®-ATR with the
The Company has numerous marketed products and products under development based upon this unique blood purification technology protected by many issued
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, representations and contentions, and the outcome of our regulatory submissions, 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, our restructuring of our direct sales team and strategy in Germany, ability to successfully obtain U.S. FDA and Health Canada marketing authorization or approval, our ability to complete our strategic workforce and cost reduction plan to reduce costs, optimize operations, and achieve cash-flow break-even in the first quarter of 2026, our ability to appropriately finance the Company, and the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 31, 2025, 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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Peter J. Mariani, Chief Financial Officer
pmariani@cytosorbents.com
Investor Relations Contacts:
Aman Patel, CFA & Adanna G. Alexander, PhD
ICR Healthcare
ir@cytosorbents.com
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SOURCE Cytosorbents Corp