CytoSorbents Announces HotSwap™ Launch, Renewed Aferetica Partnership, and New Clinical Evidence at ISICEM 2026
- 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
- 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.
"Aferetica has been an exceptional long-term partner," stated
Mr.
New Clinical Data and Scientific Leadership at ISICEM 2026
Today,
"Hemoadsorption as part of an individualized patient concept in Intensive Care – Key Learnings and Best Practices"
Chair: Dr.
-
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; only 8% 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
About
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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