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Efferon NEO is a single-use extracorporeal hemoadsorption device that Efferon says is designed for neonatal and pediatric critical care. The company reports promising results from its LASSO NEO study and announced a CE MDR milestone in April 2026. Those are company-reported findings and regulatory statements: the available sources do not provide a full LASSO NEO clinical report or establish worldwide availability.
What is Efferon NEO?
Efferon describes NEO as a pediatric device for multimodal hemoadsorption. In this approach, blood circulates outside the body through a single-use adsorber intended to remove endotoxin and inflammatory mediators. Efferon positions its devices for critical-care use in sepsis and related acute inflammatory conditions; that description is the company’s account of the technology and intended use, not independent proof of clinical effectiveness. Efferon’s company overview also identifies Efferon LPS as another device in its product line.
This is specialist equipment for clinical settings, not a consumer treatment. Sepsis management and any decision to use an extracorporeal device belong to qualified clinicians working within an appropriate care team.
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In an announcement dated 30 October 2025, Efferon described LASSO NEO (NCT05707494) as a multicenter study of 78 children aged 1 month to 14 years at eight centers. The company said 32 children received hemoadsorption and 46 were in the control group. Efferon reported these results:
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- Day-seven pSOFA score: 4.9 in the hemoadsorption group versus 7.8 in controls (p=0.006).
- Support duration: faster weaning from mechanical ventilation (p=0.003) and vasopressor support (p=0.001) in the hemoadsorption group.
- Inflammatory markers: reductions in the treated group, without specific marker values given in the announcement.
- 28-day mortality: 9% versus 35% (p=0.008; OR=0.2), as reported by Efferon.
These figures come from the company’s release, “Clinical data confirmed the effectiveness of Efferon NEO in children with sepsis,” not from a full clinical paper presented in the available sources. The scale and outcomes make the announcement notable, but the figures alone do not show how robust or generalizable the findings are.
How should the evidence be interpreted?
Efferon’s publications index lists pediatric abstracts or supplement reports and a 2023 adult septic-shock randomized trial, but it does not itself supply a full LASSO NEO report. Without the full report, readers cannot assess important details such as the protocol, prespecified analysis, confidence intervals, adverse events, or whether the mortality difference was a prespecified result. The available sources also do not establish independent replication.
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For those reasons, the reported results should be described as promising company-reported findings, not as independently established proof that Efferon NEO reduces pediatric sepsis mortality. They do not establish that the device is a cure or a replacement for standard sepsis management.
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What does the announced CE MDR milestone mean?
On 22 April 2026, Efferon announced that NEO had received a CE MDR mark for neonatal and pediatric patients with sepsis and septic shock. The company named EU QMS Certificate No. 2024-MDR/QS-024/A, issued by Notified Body 3EC International (NB 2265) on 7 April 2026. This is a company-reported European regulatory development. It should not be read as confirmation that the device is authorized or available in every country or market.
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What remains unclear to patients and clinicians?
The published company materials available here do not provide enough detail to independently appraise the LASSO NEO results or make a comparative effectiveness judgment. They also do not establish a complete picture of treatment risks, compatibility with particular extracorporeal circuits, local availability, or cost. Those questions require the full clinical report and jurisdiction-specific information from appropriate clinical and regulatory sources.
Efferon’s 2026 company page reports more than 25,000 treatments and distribution in over 40 countries, but its homepage gives different deployment totals and country counts across pages or versions. Because these are company-stated figures and the counting basis is not clear, they should not be treated as a definitive, independently audited global total.
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