On November 26, 2025, Efferon JSC launched a new clinical study investigating the use of their medical device, Efferon LPS NEO, for lipopolysaccharide adsorption in children suffering from thermal burns. The trial focuses on assessing the device’s performance, safety, and intended therapeutic benefit for this vulnerable population.
What changed?
The study, now recruiting participants, aims to evaluate how effectively Efferon LPS NEO can support children treated for burns that result in system-wide inflammation and potential complications linked to lipopolysaccharides. These molecules, known to trigger severe immune responses, can contribute to worsening conditions during burn recovery. This announcement signals progress in addressing pediatric burn care’s challenges using modern medical devices.
Details on the clinical device
Efferon LPS NEO is designed to remove lipopolysaccharides effectively from the bloodstream while prioritizing safety and minimizing adverse interactions. The medical device incorporates advanced adsorption technology engineered by Efferon JSC, who also sponsor this trial. Regulatory teams focusing on compliance should note that the study aligns with the Medical Device Regulation’s requirements for evaluating clinical performance and risk management for pediatric applications.
By targeting lipopolysaccharides, the device aims to support stabilizing inflammatory responses that are exacerbated in burn patients. This targeted therapeutic property could deliver specific benefits for vulnerable populations, particularly children, who exhibit unique physiological needs and responses.
Who is affected?
The announcement directly impacts regulatory specialists, clinical trial teams, manufacturers working in pediatric device development, and hospital systems handling burn trauma patients. For clinical practitioners, this trial could introduce a new standard in effective immune modulation devices for specific burn-related complications.
Quality managers and regulatory teams will likely track this study as part of oversight or evidence gathering for respective regulatory submissions, particularly MDR Annex XIV provisions concerning pediatric device performance evidence.
Implications for industry
This announcement reinforces the importance of advancing pediatric-specific treatments in medical devices. Stakeholders specializing in pediatric therapeutic innovations should pay close attention to the progress and outcomes of this trial.
Frequently Asked Questions
- What condition is under study? The Efferon LPS NEO trial focuses on burns and their systemic complications.
- What is the intended purpose of Efferon LPS NEO? The device aims to adsorb lipopolysaccharides linked to immune responses in burn recovery.
- Who sponsors this study? The sponsor for the trial is Efferon JSC.
- Where can prospective participants learn more? Full study details are available via ClinicalTrials.gov.
Conclusion
The ongoing clinical study for Efferon LPS NEO marks an important exploration into improving burn recovery outcomes in children. Regulatory and clinical stakeholders should monitor developments closely as the device moves through compliance testing and performance evaluation stages.
Disclaimer
This blog provides informational content only and does not constitute professional or legal advice on regulatory compliance.
Access full study details
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07248930?term=medical+device